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.
1. Subject is symptomatic with Severe TR despite being optimally treated as described in (1). TR severity is determined by the assessment of a qualifying TTE and confirmed by the ECL. The ECL may request a TEE to confirm TR etiology. Note: If any cardiac procedure(s) occur after eligibility was determined, TR severity will need to be re-assessed 30 days after the cardiac procedure(s). 2. The cardiac surgeon of the Site Heart Team concur that the patient is at intermediate or greater estimated risk of mortality with tricuspid valve surgery. 3. New York Heart Association (NYHA) Functional Class II, III or ambulatory class IV
Detailed Eligibility: Subjects must meet all of the following inclusion criteria in order to participate in the trial: 1. In the judgment of the sites local heart team, subject has been adequately treated per applicable standards (including medical management) and stable for at least 30 days as follows: • Optimized medical therapy for treatment of TR (e.g. diuretics) • Medical and/or device therapy, for mitral regurgitation, atrial fibrillation, coronary artery disease and heart failure The EC will confirm that the subject has been adequately treated medically. 2. Subject is symptomatic with Severe TR despite being optimally treated as described in (1). TR severity is determined by the assessment of a qualifying TTE and confirmed by the ECL. The ECL may request a TEE to confirm TR etiology. Note: If any cardiac procedure(s) occur after eligibility was determined, TR severity will need to be re-assessed 30 days after the cardiac procedure(s). 3. The cardiac surgeon of the Site Heart Team concur that the patient is at intermediate or greater estimated risk of mortality with tricuspid valve surgery. 4. New York Heart Association (NYHA) Functional Class II, III or ambulatory class IV 5. In the judgment of the TriClipTM implanting Investigator, femoral vein access is determined to be feasible and can accommodate a 25 Fr catheter. 6. Age ≥18 years at time of consent. 7. Subject must provide written informed consent prior to any trial related procedure. 6.3.2 Exclusion Criteria Subjects who meet any of the following exclusion criteria may not participate in the trial: 1. Systolic pulmonary artery pressure (sPAP) > 70 mmHg or fixed pre-capillary pulmonary hypertension as assessed by right heart catheterization (RHC) 2. Severe uncontrolled hypertension Systolic Blood Pressure (SBP) ≥ 180 mmHg and/or Diastolic Blood Pressure (DBP) ≥ 110 mm Hg) 3. Any prior tricuspid valve procedure that would interfere with placement of the TriClipTM device 4. Indication for left-sided (e.g. severe aortic stenosis, severe mitral regurgitation) or pulmonary valve correction prior 60 days. Note: Patients with concomitant Mitral and tricuspid valve disease will have the option of getting their MR treated, and wait 60 days prior to being reassessed for the trial. 5. Pacemaker or ICD leads that would prevent appropriate placement of the TriClipTM Clip. 6. Tricuspid valve stenosis - Defined as a tricuspid valve orifice of ≤ 1.0 cm2 and/or mean gradient ≥5 mmHg as measured by the ECL 7. Left Ventricular Ejection Fraction (LVEF) ≤20% 8. Tricuspid valve leaflet anatomy which may preclude clip implantation, proper clip positioning on the leaflets or sufficient reduction in TR. This may include: a. Evidence of calcification in the grasping area b. Presence of a severe coaptation defect (> 2cm) of the tricuspid leaflets c. Severe leaflet defect(s) preventing proper device placement d. Ebstein Anomaly - Identified by having a normal annulus position while the valve leaflets are attached to the walls and septum of the right ventricle. 9. Tricuspid valve anatomy not evaluable by TTE and TEE 10. Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e. noncompliant, perforated). 11. MI or known unstable angina within prior 30 days 12. Percutaneous coronary intervention within prior 30 days 13. Hemodynamic instability defined as systolic pressure < 90 mmHg with or without afterload reduction, cardiogenic shock or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device. 14. Cerebrovascular Accident (CVA) within prior 90 days 15. Chronic dialysis 16. Bleeding disorders or hypercoagulable state 17. Active peptic ulcer or active gastrointestinal (GI) bleeding 18. Contraindication, allergy or hypersensitivity to dual antiplatelet and anticoagulant therapy Note: Contraindication to either antiplatelet or anticoagulant the
Not Applicable - Describes studies without FDA-defined phases, including studies of devices or behavioral interventions.
University of Colorado Hospital
John Carroll, MD
Protocol Number: 19-1823
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