Assessing the Impact of Therapy on Localized Intravascular Coagulopathy in Vascular AnomaliesProtocol #: 20-2139 Location: Childrens Hospital Colorado |
STOP BLOQ: (Surveillance and Treatment to Prevent Fetal Atrioventricular Block Likely to Occur Quickly)Protocol #: 20-1310 Location: Childrens Hospital Colorado |
An open-label, repeat-application, intra-subject, dose escalation (Part 1) followed by a randomized, double-blind, placebo-controlled (Part 2) trial of topical VT30 in subjects with venous, lymphatic or mixed malformations associated with PIK3CA or TEK genetic mutationsProtocol #: 20-1757 Location: Childrens Hospital Colorado |
Treatment Related Patient Reported Outcomes in Severe Pediatric Aplastic AnemiaProtocol #: 20-1333 Location: Childrens Hospital Colorado |
Post Event-Cardiovascular Risk Perception Survey (PE-CRPS): Validity and Reliability in Cardiac Patients Post Heart EventThe purpose of the study is to test for validity and reliability in the revised Post Event Cardiovascular Risk Perception Survey (PE-CRPS) among individuals who are diagnosed with heart disease (post heart event). The purpose of the study is to test for validity and reliability in the revised Post EventCardiovascular Risk Perception Survey (PE-CRPS) among individuals who are diagnosed with heart disease (post heart event). The researchers plan to learn more about how individuals perceive their chance of developing certain cardiac risk factors after they have had a heart event such as after having a heart attack, or having cardiac surgery. If you join the study you will help us learn about: 1) what patients perceive their chance of developing certain cardiac risk factors, 2) how to structure cardiac rehab programs. Protocol #: 20-6019 Location: Memorial Hospital Central |
OPTIONThis study is a prospective, randomized, multi-center, global investigation to determine if left atrial appendage closure with the WATCHMAN FLX Device is a reasonable alternative to oral anticoagulation in patients after AF ablation. Protocol #: 20-6502 Location: Medical Center of the Rockies |
Slow Heart Registry: A prospective observational cohort study of fetal immune-mediated high degree heart blockProtocol #: 20-0820 Location: Childrens Hospital Colorado |
OPTIMIZE PAD-1: Implementation of Vascular Care Team to Improve Medical Management of PAD PatientsPatients with PAD and elevated LDL-C who are cared for at the University of Colorado (UC) and who provide consent will be randomized 1:1 to Intervention A, a vascular care team approach including pharmacy and healthcare provider assistance with medication adherence, versus Intervention B consisting of standard care augmented with a single consultation with a Vascular Medicine physician who will provide the treating doctor with a personalized risk assessment for the patient and a summary of the 2018 American College of Cardiology (ACC)/American Heart Association (AHA) Guideline on Management of Blood.1 There will also be an observational cohort (registry) to understand current practice patterns and outcomes in a non-interventional PAD population within the UC Health system in order to assess the potential impact of Intervention A after conclusion of the randomized study. Protocol #: 20-0288 Location: University of Colorado Hospital |
Prospective, randomized, double-blinded, placebo-controlled clinical investigation of advanced heart failure patients treated with the HM3 with two different antithrombotic regimens: vitamin K antagonist with aspirin versus vitamin K antagonist with placeboThis clinical investigation is a prospective, randomized, double-blinded, placebo-controlled study of advanced heart failure patients treated with the HM3 with two different antithrombotic regimens: vitamin K antagonist with aspirin versus vitamin K antagonist with placebo. The objective of this investigation is to study the safety and efficacy of an anti-platelet-free antithrombotic regimen in patients with advanced heart failure treated with the HM3 LVAS. Protocol #: 20-0254 Location: University of Colorado Hospital |
The impact of feminizing gender-affirming hormone therapy on biomarkers of coagulation and thrombosis in transgender womenProtocol #: 20-0104 Location: University of Colorado Hospital |
A Phase 3 Global, Double-Blind, Randomized, Placebo‑Controlled Study to Evaluate the Efficacy and Safety of ION-682884 in Patients with Transthyretin‑Mediated Amyloid Cardiomyopathy (ATTR CM)Randomized, double-blind, placebo-controlled study of ION‑682884 vs. placebo administered by SC injection once every 4 weeks for 120 weeks in patients with ATTR-CM receiving available background SoC. Patients will be stratified at Randomization based on NYHA Classification (I and II vs. III), ATTR mutation status (mutated vs. wild-type), 6MWT (≤ 350 meters vs. > 350 meters), and current treatment with tafamidis (Yes vs. No). Study Drug (ION‑682884 or placebo) will be administered for 120 weeks (Treatment Period) followed by an additional 20 weeks of Post-Treatment Evaluation Period. Protocol #: 19-2854 Location: University of Colorado Hospital |
A Randomized, Controlled Phase 3 Study of Pacritinib Versus Physician s Choice in Patients with Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post Essential Thrombocythemia Myelofibrosis with Severe Thrombocytopenia (Platelet Counts <50,000/μL)Protocol #: 19-2788 Location: University of Colorado Hospital |
Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP II TR): A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter tricuspid valve repair with the Edwards PASCAL Transcatheter Valve Repair System and optimal medical therapy (OMT) compared to OMT alone in patients with tricuspid regurgitationA prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter tricuspid valve repair with the Edwards PASCAL Transcatheter Valve Repair System and optimal medical therapy (OMT) compared to OMT alone in patients with tricuspid regurgitation Protocol #: 19-6129 Locations: Harmony Campus; Medical Center of the Rockies |
A Randomized Study of Daratumumab Plus Lenalidomide Versus Lenalidomide Alone as Maintenance Treatment in Patients with Newly Diagnosed Multiple Myeloma Who are Minimal Residual Disease Positive After Frontline Autologous Stem Cell Transplant (AURIGA)Protocol #: 19-6114 Locations: Greeley Campus; Harmony Campus; Medical Center of the Rockies; Poudre Valley Hospital |
A RANDOMIZED, OPEN-LABEL, ACTIVE CONTROLLED, SAFETY AND DESCRIPTIVE EFFICACY STUDY IN PEDIATRIC SUBJECTS REQUIRING ANTICOAGULATION FOR THE TREATMENT OF A VENOUS THROMBOEMBOLIC EVENTProtocol #: 15-1434 Location: Childrens Hospital Colorado |
Personalized experiences to inform improved communication for patients with Life Limiting IllnessFor Aim 1, this study will test: 1) the effects on quality of communication between patient and nurse, as measured by the patient, 2) the effect of the intervention on patient’s overall biopsychosocial and spiritual well-being, as measured by the PROMIS 29 profile, and 3) the effects on patient’s psychosocial illness impact, as measured by the PROMIS psychosocial illness impact. For Aim 2, this study will test acceptability, feasibility, and usability of the narrative intervention from the perspectives of the key stakeholders—patients with serious illness and acute-care bedside nurses via 1) patient and nurse exit interviews, 2) field analysis of EHR interface use, and 3) end-user usability surveys of the nurses. Protocol #: 19-1874 Location: University of Colorado Hospital |
Clinical TRIal to EvaLUate Cardiovascular OutcoMes IN PAtients Treated with the Tricuspid ValvE Repair System Pivotal (TRILUMINATE Pivotal)The objective of this trial is to evaluate the safety and effectiveness of the TriClipTM device in improving clinical outcomes in symptomatic patients with severe TR who have been determined by the site’s local heart team to be at intermediate or greater estimated risk for mortality with tricuspid valve surgery. Protocol #: 19-1823 Location: University of Colorado Hospital |
Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (STELLAR)Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation To demonstrate the safety based on the incidence of early-onset (within 7 days of ablation procedure) primary adverse events. To demonstrate the 12-month effectiveness based on the proportion of subjects with freedom from documented asymptomatic and symptomatic Atrial Fibrillation, Atrial Tachycardia, or Atrial Flutter episodes Protocol #: 19-6101 Locations: Harmony Campus; Medical Center of the Rockies |
Safety and Effectiveness Evaluation of the Multi-Electrode Radiofrequency Balloon Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (STELLAR)This clinical study is a prospective, multicenter, single-arm clinical evaluation of the Multi-Electrode Radiofrequency (RF) Balloon catheter. The purpose of this study is to evaluate the overall safety and effectiveness of the Multi-Electrode RF Balloon catheter, in conjunction with the Multi-Electrode Circular Diagnostic catheter and Multi-Channel RF Generator, for the treatment of drug refractory Paroxysmal Atrial Fibrillation (PAF). Embedded within the Main Study will be a Neurological Assessment Evaluable (NAE) subset and a Cardiac Computed Tomography (CT) or Magnetic Resonance Angiogram (MRA) image (CT/MRA) subset with consecutive enrollment and a prospective design. The same subject can participate in both the NAE and cardiac CT/MRA subsets. The study will enroll subjects with drug refractory, symptomatic PAF who are candidates for catheter ablation. The first 1-3 subjects for each ablating physician will be considered roll-in subjects to verify consistent workflow for study device components and to minimize any learning curve effects. The roll-in subjects will not be included in the NAE subset, cardiac CT/MRA subset, or in the primary endpoint analyses. The roll-in phase will include a maximum of 240 subjects and the main study phase will include a maximum of 400 evaluable subjects. Subjects will be evaluated prior to the procedure, prior to discharge, and post procedure at 7 days (7-14 days), 1 month (23-37 days), 3 months (76- 104 days), 6 months (150-210 days), and 12 months (315-405 days) unless otherwise specified in the protocol. Protocol #: 19-1679 Location: University of Colorado Hospital |
A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Impact of Evolocumab on Major Cardiovascular Events in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or StrokeThis is a clinical study sponsored by Amgen Inc. It is a study being done for patients that are at high risk for experiencing a cardiovascular event (like a heart attack or stroke). Elevated cholesterol, in particular low-density lipoprotein cholesterol (LDL-C), can lead to obstructing fatty deposits in blood vessels that can greatly increase the risk of developing cardiovascular disease or experiencing a cardiovascular event. The purpose of this research study is to assess whether lowering of cholesterol blood level can reduce your risk for major cardiovascular events (for example, heart attack or stroke) when evolocumab is taken in addition to current medical therapy as directed by a doctor, which may include a medication for the treatment of abnormal cholesterol blood levels called statins. Protocol #: 19-6511 Location: Memorial Hospital Central |
ECG Belt for CRT ResponseDemonstrate benefit of using the ECG Belt Research System on reducing left ventricular end-systolic volume (LVESV) from baseline to 6 months post-implant compared to standard CRT. ECG Belt arm subjects will be compared with the control arm subjects (combined control arms A and B). A core lab blinded to randomization and follow up status will analyze the echo data and measure LVESV. Demonstrate benefit of using the ECG Belt Research System on reducing left ventricular end-systolic volume (LVESV) from baseline to 6 months post-implant compared to standard CRT. ECG Belt arm subjects will be compared with the control arm subjects (combined control arms A and B). A core lab blinded to randomization and follow up status will analyze the echo data and measure LVESV. Protocol #: 19-1703 Location: University of Colorado Hospital |
A Phase 2/3 Randomized, Double-blind, Palivizumab-controlled Study to Evaluate the Safety of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in High-risk Children (MEDLEY)MEDLEY is a clinical study to research an investigational medicine for babies at high risk for respiratory syncytial virus (RSV) disease. The study is looking to see how safe the investigational medication is and if it works as well as a medication already approved to protect against RSV. The study will include about 1500 babies globally. If you decide to take part, your baby may be in the MEDLEY Study for up to 2 years and may have up to 17 scheduled study visits. Your baby will be monitored throughout the study for respiratory illnesses. Protocol #: 19-1403 Location: Childrens Hospital Colorado |
Comparison of Anticoagulation with Left Atrial Appendage Closure after AF AblationThis is a study for patients that have a heart condition in which the upper chambers of your heart beat irregularly. This condition, also known as atrial fibrillation, can cause blood clots to form in an area of your heart called the left atrial appendage (LAA). Everyone has a LAA, which is like a pouch on the top of your heart, and it developed along with the other parts of the heart before birth. If a clot forms here, it can increase your chances of having a stroke or other related problems. Because you have atrial fibrillation, it is believed that if the LAA is closed, then blood clots might not be able to form in that area. The current standard of care to prevent stroke in patients with atrial fibrillation is long-term oral anticoagulation (OAC) therapy (blood thinner medication) or, in appropriately selected patients, implant of the commercial WATCHMANTM device followed by short-term OAC therapy. Protocol #: 19-6506 Location: Memorial Hospital Central |
Cardiopulmonary and Right Ventricular Function in Health and DiseaseThe primary objective of this research protocol is to advance the understanding of cardiopulmonary and right ventricular (RV) performance among individuals with cardiomyopathy (heart failure with reduced ejection fraction [HFrEF], heart failure with preserved ejection fraction [HFpEF]), as well as athletes engaging in endurance/prolonged exercise, who are at a high risk of an acquired cardiomyopathy during/following completion of an endurance event. Examine the heart function of elite athletes and heart failure patients utilizing a novel catheter system. Protocol #: 19-1141 Location: University of Colorado Hospital |
Evaluation and Demonstration of Investigational MRI Software and HardwareTest new MRI scanner sequences in diverse patient population Protocol #: 19-0518 Location: Childrens Hospital Colorado |
An Open-Label, Single Arm, Multicenter Study to Broaden Access to Emapalumab, an Anti-Interferon Gamma (Anti-IFNy) Monoclonal Antibody, and to Assess its Efficacy, Safety, Impact on Quality of Life, and Long-term Outcome in Pediatric Patients with Primary Hemophagocytic LymphohistiocytosisProtocol #: 19-0105 Location: Childrens Hospital Colorado |
SELECT: SELExipag in inoperable or persistent/recurrent Chronic Thromboembolic pulmonary hypertension: A multicenter, randomized, double-blind, placebo-controlled, parallel-group, group-sequential, adaptive, Phase 3 study with open-label extension period to assess the efficacy and safety of selexipag as an add-on to standard of care therapy in subjects with inoperable or persistent/recurrent after surgical and/or interventional treatment Chronic Thromboembolic Pulmonary Hypertension.This is a 52 week blinded study in which the subject would recieve either Selexipag or Pacebo. Study visits are approximately every 6 to 12 weeks and study participants may be eligible for the open label extension at the end of 52 weeks. Protocol #: 19-0347 Location: University of Colorado Hospital |
APOGEELVAD registry Protocol #: 18-2576B Location: University of Colorado Hospital |
GORE? CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients with Patent Foramen Ovale (PFO): the REDUCE Post Approval StudyThis study will assess the safety and effectiveness of GORE? CARDIOFORM Septal Occluder in a post approval setting and evaluate the quality of operator education and training and transferability of trial experience to a post-market setting. Protocol #: 19-6030 Locations: Harmony Campus; Medical Center of the Rockies |
Evaluation of the VISITAG SURPOINT Module with External Processing Unit (EPU) when used with the THERMOCOOL SMARTTOUCH SF and the THERMOCOOL SMARTTOUCH Catheters for Pulmonary Vein Isolation (PVI)The SURPOINT COA study is a prospective, multicenter, non-randomized post-market clinical evaluation of the VISITAG SURPOINT™ Module with EPU when used with the STSF/ST catheters in treating subjects with symptomatic PAF who have failed at least one antiarrhythmic drug. A total of 330 subjects will be enrolled at up to 45 sites. Two hundred eighty (280) enrolled subjects will be treated using the STSF catheter with EPU and fifty (50) subjects will be treated with ST catheter. Prior to enrollment, a few sites will be selected to only enroll subjects who will be treated with the ST catheter and the remaining sites will only enroll subjects who will be treated with the STSF catheter. Effectiveness and safety endpoints have been defined, and will be compared to predetermined performance goals. Subjects who sign the SURPOINT COA informed consent are considered enrolled in the study. Enrolled subjects who satisfy all eligibility criteria will then undergo the ablation procedure with the catheter and VISITAG SURPOINT™ Module. After the study ablation procedure, subjects will enter a 3-Month blanking period (Day 0-90). After the Blanking Period, subjects will enter the Evaluation Period (Days 91-365). Subjects having AF recurrence and/or receiving therapeutic interventions during the evaluation period will be considered effectiveness failures (refer to Section 4.1.1 for all effectiveness failure modes). All subjects will undergo follow up visits at defined intervals (refer to Table 5-1 Schedule of Treatments and Evaluations). Subjects complete the SURPOINT COA study after the 12-month follow up visit. Protocol #: 19-0003 Location: University of Colorado Hospital |
Early Feasibility Study of the Edwards Transcatheter Atrial Shunt SystemAdult patients with symptomatic clinically significant heart failure and elevated left atrial pressure despite guideline directed medical therapy (GDMT). Protocol #: 18-2765 Location: University of Colorado Hospital |
A double-blind randomized placebo-controlled trial assessing the effects of inclisiran on clinical outcomes among people with atherosclerotic cardiovascular diseaseAbout 15,000 people will take part in this study. Half will get inclisiran injections and half will get dummy placebo) injections. A placebo is a substance that looks like a drug, but has no drug in it. This form will refer to both inclisiran and placebo as “study drug.” Which study drug you get is decided by chance and you will not know which study drug you are given. Joining the study involves 3 clinic visits in the first 5 months and then a visit every 6- months. At each visit a trained researcher will ask some questions about your health, take a blood sample, and give you an injection into your abdomen (tummy). It is expected that about 1 in 20 people administered inclisiran may notice some redness or soreness where the injection is given, but no other side effects have been found. However, at this stage, scientists cannot rule out the possibility of other side effects. You are asked to stay in the study for about 5 years. Protocol #: 18-6511 Location: Memorial Hospital Central |
GB001-1101:A Phase 1b, Randomized, Subject- and Investigator-Blinded, Placebo-Controlled, Multi-Center Clinical Trial to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Biomarkers of Inhaled GB002 in Subjects with WHO Group 1 Pulmonary Arterial Hypertension (PAH)This is a multicenter, randomized, blinded and placebo controlled study in subjects with WHO group 1 Pulmonary Arterial Hypertension who will recieve inhaled GB002 or matching placebo for 14 days. The subject will have to visit the clinic for screening and on days 1, 2, 8 and 14. The patient has the option of having a visiting nurse come to them on days 3 to 7 to verify that they are following instrctions for dosing of the study drug and completing their study diary correctly. There will also be a follow up telephone call on days 15 and 42 to assess the patient's physical status and record any additional medications being taken. On day 1 and day 14, the visit will last up to 6 hours and the patient will have 5 blood draws during that time to assess drug levels in the blood and on days 2 and 8, the visi will last up to 2 hours and the patient will have one blood level drawn on these days. Protocol #: 18-2672 Location: University of Colorado Hospital |
CLASP IID/IIFPASCAL System (vs. MitraClip) in treatment of symptomatic degenerative mitral regurgitation Protocol #: 18-6126 Locations: Harmony Campus; Medical Center of the Rockies |
Destination Therapy Post Approval Study - Medtronic HVAD SystemLVAD registry Protocol #: 18-2576A Location: University of Colorado Hospital |
Phase IIb Study of Intramyocardial Injection of Autologous Umbilical Cord Blood Derived Mononuclear Cells during Stage II Surgical Repair of Hypoplastic Left Heart Syndrome (Auto Cell-II)Umbilical cord blood is collected at birth and shipped to ReGen Theranostics, Inc for manufacturing. The umbilical cord blood mononuclear cells (MNC) are isolated from the cord blood and frozen. The cells are then transported to the study site when the patient undergoes the Glenn surgery. This study will evaluate the efficacy and safety of UCB-MNC intramyocardial injections performed during Stage II surgical palliation by focusing on short and long-term cardiac function leading up to the pre-op work-up for Stage III surgical palliation. Protocol #: 18-2012 Location: Childrens Hospital Colorado |
A phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy and safety of CSL112 in subjects with acute coronary syndrome.The primary objective of this study is to evaluate the efficacy of CSL112 on reducing the risk of MACE (CV death, MI, or stroke) from the time of randomization through 90 days in subjects with ACS (diagnosed with STEMI or NSTEMI) Protocol #: 18-6081 Locations: Harmony Campus; Medical Center of the Rockies |
FLExAbility Sensor Enabled Substrate Targeted Ablation for the Reduction of VT (LESS-VT) StudyThe objective of the LESS-VT Clinical Trial is to demonstrate that substrate ablation with the FlexAbility SE catheter is safe and effective in reducing the occurrence of MMVT in patients in whom VT recurs despite antiarrhythmic drug therapy or when AAD are not tolerated or desired. Protocol #: 18-1148 Location: University of Colorado Hospital |
EMPERIAL-reduced: A phase III randomized, double-blind trial to evaluate the effect of 12 weeks treatment of once daily EMPagliflozin 10 mg compared with placebo on ExeRcise ability and heart failure symptoms, In patients with chronic HeArt FaiLure with reduced Ejection Fraction (HFrEF)Participants will be randomly assigned to empagliflozin or placebo. Participants will take the study medication (empagliflozin or placebo) for 12 weeks. Protocol #: 18-0926 Location: University of Colorado Hospital |
EMPERIAL-preserved: A phase III randomized, double-blind trial to evaluate the effect of 12 weeks treatment of once daily EMPagliflozin 10 mg compared with placebo on ExeRcise ability and heart failure symptoms, In patients with chronic HeArt FaiLure with preserved Ejection Fraction (HFpEF)Subjects enrolled in this trial will be randomly assigned to receive either Empagliflozin 10 mg or placebo for 12 weeks. Protocol #: 18-0925 Location: University of Colorado Hospital |
PERFECT: A Phase 3, Randomized. Placebo-Controlled, Double Blind, Adaptive Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Patients with Pulmonary Hypertension due to Chronic Obstructive Pulmonary Disease (PH-COPD)This study is a 34 week cross over study with a treatment period of 26 weeks. After screening criteria is met, the subject will receive either active drug or placebo, have a one week "washout" period in which the subject will not receive any medication, then the subject will have another 12 weeks of treatment. (If the subject received active drug in the first 12 weeks he/she will receive placebo during this 12 weeks and previous placebo subjects will receive active drug. Procedures that will be conducted during the study are: completion of quality of life questionnaires, EKGs, laboratory assessments, Pulmonary Function tests, and 6 minute walk tests. Each visit will take approximately 2 hours. Protocol #: 18-0761 Location: University of Colorado Hospital |
AMPLATZER Amulet Left Atrial Appendage Occluder Randomized Controlled TrialProtocol #: 16-6109-2N Location: Medical Center of the Rockies |
Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation (SUMMIT) (the "trial")Prospective, controlled, multicenter clinical investigation of the Tendyne Mitral Valve System for the treatment of eligible subjects with symptomatic, severe mitral regurgitation Subjects will be assigned to either a surgical or a non-surgical arm, at the discretion of the local site heart team. Subjects must satisfy the trial inclusion/exclusion criteria, and be approved by the Subject Eligibility Committee (SEC), prior to inclusion in the trial. Surgical arm: Subjects whom the local site heart team determines are appropriate for mitral valve surgery will be randomized in a 2:1 ratio to the Tendyne device (Treatment group) or to standard of care surgical repair or total chordal-sparing surgical replacement (Control group). Randomization will be stratified by investigational site. Non-surgical arm: Subjects whom the local site heart team determines are not appropriate for mitral valve surgery and whose valve anatomy is not suitable for transcatheter repair, will be eligible to enroll into the non-surgical arm in which all subjects will receive the Tendyne device. Protocol #: 18-0505 Location: University of Colorado Hospital |
Education Efficacy in Patient InterventionsProtocol #: 18-6020 Location: Medical Center of the Rockies |
Aquaman: Treatment of Exercise-Induced Pulmonary Vascular Dysfunction After Pulmonary ThromboendoarterectomyThis is a 3 month study to see if riociguat improves RHC measurements and exercise tolerance. There are 2 study visits - one at the beginning and one at the end - during which the subject will undergo a 6 MWT as well as a resting RHC and an exercise RHC. Study drug will be uptitrated at week 2, 4 and 6 via the telephone. Protocol #: 17-2349 Location: University of Colorado Hospital |
An Open-Label Study to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Subjects with Thrombocytopenia Scheduled for a Surgical ProcedureThe purpose of this study is to test the safety and effectiveness of the study drug, avatrombopag, in subjects with thrombocytopenia undergoing an operation. Patients will receive either 60mg or 80mg of avatrombopag once daily by mouth for 5 days prior to surgery Protocol #: 18-0546 Location: University of Colorado Hospital |
Pulse Reduction on Beta Blocker and Ivabradine Therapy (PROBE-IT)The goals of this study are (1) to test the hypothesis that HR reduction is an important underlying antecedent for reverse remodeling, and (2) to identify components of the beta1-GSN responsible for reverse remodeling caused by HR reduction using ivabradine, which could allow for better drug targeting. This study will also yield hypothesis-generating data on whether ivabradine might be useful in earlier stage HFrEF patients than the current indication. Protocol #: 16-1363 Location: University of Colorado Hospital |
Randomized Controlled Pivotal Trial of Autologous Bone Marrow Mononuclear Cells Using the CardiAMP Cell Therapy system in Patients with Post Myocardial Infarction Heart FailureThis study examines the use of stem cells to help the hearts of people who have heart failure as a result of a heart attack. Study subjects are randomized 3:2 to the treatment arm using the CardiAMP cell therapy system (Treatment Group) vs. a sham control. Subjects will be evaluated for 12 months thereafter to determine whether there is an improvement in walking distance, future heart attacks or hospitalizations, and/or survival. Protocol #: 18-0158 Location: University of Colorado Hospital |
A Phase 3, Multinational, Randomized, Placebo-controlled Study of ARRY-371797 in Patients with Symptomatic Dilated Cardiomyopathy Due to a Lamin A/C Gene MutationsThis multinational Phase 3 study will evaluate the efficacy, safety and PK following treatment with ARRY-371797 compared with placebo (1:1 randomization) in at least 120 patients with NYHA functional Class II and III DCM secondary to LMNA mutations. NYHA functional Class IV patients (up to approximately 40) will ARRY-371797 (p38 MAP Kinase Inhibitor) Array BioPharma Inc. Clinical Study ARRAY-797-301 Protocol Version 2 7 Confidential 23 October 2017 also be enrolled (1:1 randomization) and will be assessed for overall safety and time from randomization to HF-related hospitalization or death due to any cause, in addition to PK and efficacy, if feasible. For the Class IV patients, some assessments (i.e., 6MWT, triplicate ECGs, echocardiograms (ECHO), arrhythmia, PK assessment and PD assessment) are considered optional based on whether the patient is ambulatory or not. Protocol #: 17-2345 Locations: CTRC-adult; University of Colorado Hospital |
EARLY-TAVR Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients with AsYmptomatic Severe Aortic StenosisProtocol #: 17-6134 Locations: Greeley Campus; Harmony Campus; Long's Peak Hospital; Longs Peak Hospital; Medical Center of the Rockies |
MOMENTUM 3 Multi-Center Study of MagLev Technology in Patients Undergoing MCS Therapy with HeartMate 3?Protocol #: 16-2506 Location: University of Colorado Hospital |
Transcatheter Aortic Valve Replacement to UNload the Left ventricle in patients with ADvanced heart failure: a randomized trial (TAVR UNLOAD)Protocol #: 17-6209 Locations: Medical Center of the Rockies; Memorial Hospital Central |
Transcatheter Aortic Valve Replacement With the Medtronic Transcatheter Aortic Valve Replacement System In Patients at Low Risk for Surgical Aortic Valve ReplacementProtocol #: 16-0696 Location: University of Colorado Hospital |
A clinical trial of an Electronic health record-leveraged, Patient-centered, Intensification of Chronic care for Heart Failure (EPIC-HF) patient engagement video and medication options checklistProtocol #: 17-1249 Locations: Harmony Campus; Medical Center of the Rockies; Memorial Hospital Central; Memorial Hospital North; Poudre Valley Hospital; University of Colorado Hospital |
Randomized Observation of Biventricular pacemakers on ventrIcular function among patients with mechaNical circulatory support devices: "ROBIN"Protocol #: 17-1042 Location: University of Colorado Hospital |
PARTNER 3: A Prospective, Single-Arm, Multicenter Study to Investigate the Safety and Effectiveness of SAPIEN 3 Transcatheter Heart Valve Implantation in Patients With a FailingTo assess the safety and effectiveness of the SAPIEN 3 (Edwards Lifesciences, Irvine, California) transcatheter heart valve in patients with a failing aortic bioprosthetic valve. Protocol #: 17-6104 Locations: Harmony Campus; Medical Center of the Rockies |
PHANTOM: Anastrozole in Patients with Pulmonary Arterial HypertensionProtocol #: 17-0536 Location: University of Colorado Hospital |
Measurement of Hematopoietic Stem Cell Derived AdipocytesThe purpose of this study is to learn more about where the fat tissue in your body originates. For many years it has been thought that all fat cells come from cells that are from the fat tissue itself, but now we know it is possible that some fat cells may originally come from the bone marrow. Understanding the origin of fat cells is important because it may help to determine the health of fat cells. You are being asked to be in this research study because you are a person over the age of 18 who has had a hematopoietic stem cell transplant or has chronic phase chronic myeloid leukemia (CML). To understand if some fat cells (adipocytes) may originally come from cells in the bone marrow. Understanding the origin of fat cells is important because it may help to determine the health of fat cells and why fat that is stored in some places of your body is more unhealthy than other fat. Protocol #: 13-0026 Location: University of Colorado Hospital |
Effect of Mechanical Circulatory Support on Exercise Capacity in Heart FailureProtocol #: 16-1635 Locations: Colorado Research Center; CTRC-adult; University of Colorado Hospital |