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Early Feasibility Study of the Edwards Transcatheter Atrial Shunt System

Study category: Heart and Blood Conditions

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Description

Adult patients with symptomatic clinically significant heart failure and elevated left atrial pressure despite guideline directed medical therapy (GDMT).

Details
Age

Adult

Eligibility

Chronic symptomatic Heart Failure (HF) documented by the following: a. NYHA class II with a history of NYHA class > II; NYHA class III; or ambulatory NYHA class IV AND b. ≥ 1 HF hospital admission (with HF as the primary, or secondary diagnosis); or treatment with intravenous (IV) or intensification of oral diuresis for HF in a healthcare facility (emergency department/acute care facility) within the 12 months prior to study entry; OR an NT-pro BNP value > 150 pg./ml in normal sinus rhythm, > 450 pg./ml in atrial fibrillation, or a BNP value > 50 pg./ml in normal sinus rhythm, > 150 pg./ml in atrial fibrillation within the past 6 months. 4. In the judgment of the investigator, subject is on stable Guideline Directed Medical Therapy (GDMT) for heart failure and management of potential comorbidities according to current ACCF/AHA Guidelines and that is expected to be maintained without change for 3 months 5. Elevated LA (or PCWP) pressure of > 15 mmHg at rest or > 25 mmHg during supine ergometer exercise stress test, as measured at end-expiration; AND the LA (or PCWP) exceeds right atrial pressure (RAP) by > 5 mmHg at rest or > 10 mmHg during supine ergometer exercisestress test as measured at end-expiration

Detailed Eligibility: Enrollment Criteria (Inclusion): 1. Signed and dated IRB approved study consent form prior to study related procedures 2. ≥ 18 years old 3. Chronic symptomatic Heart Failure (HF) documented by the following: a. NYHA class II with a history of NYHA class > II; NYHA class III; or ambulatory NYHA class IV AND b. ≥ 1 HF hospital admission (with HF as the primary, or secondary diagnosis); or treatment with intravenous (IV) or intensification of oral diuresis for HF in a healthcare facility (emergency department/acute care facility) within the 12 months prior to study entry; OR an NT-pro BNP value > 150 pg./ml in normal sinus rhythm, > 450 pg./ml in atrial fibrillation, or a BNP value > 50 pg./ml in normal sinus rhythm, > 150 pg./ml in atrial fibrillation within the past 6 months. 4. In the judgment of the investigator, subject is on stable Guideline Directed Medical Therapy (GDMT) for heart failure and management of potential comorbidities according to current ACCF/AHA Guidelines and that is expected to be maintained without change for 3 months 5. Elevated LA (or PCWP) pressure of > 15 mmHg at rest or > 25 mmHg during supine ergometer exercise stress test, as measured at end-expiration; AND the LA (or PCWP) exceeds right atrial pressure (RAP) by > 5 mmHg at rest or > 10 mmHg during supine ergometer exercisestress test as measured at end-expiration 6. Willing to attend study follow-up assessments for up to 5 years Enrollment Criteria (Exclusion): 1. Severe heart failure defined as one or more of the below: a. ACC/AHA/ESC Stage D heart failure, non-ambulatory NYHA Class IV HF b. If BMI < 30, Cardiac index < 2.0 L/min/m2 c. If BMI > 30, cardiac index < 1.8 L/min/m2 d. Inotropic infusion (continuous or intermittent) within the past 6 months e. Patient is on the cardiac transplant waiting list f. LVEF < 20% 2. Presence of significant valve disease defined by the site cardiologist as: a. Mitral valve regurgitation defined as grade > 3+ MR b. Tricuspid valve regurgitation defined as grade > 2+ TR c. Aortic valve disease defined as > 2+ AR or > moderate AS 3. MI and/or any therapeutic invasive cardiac procedure within past 3 months; or current indication for coronary revascularization 4. Valve replacement or surgical annuloplasty within the past 12 months 5. Cardiac Resynchronization Therapy initiated, stroke or transient ischemic attack (TIA) within the past 6 months 6. Hemodynamic instability within 30 days of scheduled implant procedure 7. Patient requiring surgery under general anesthesia for any reason within 30 days of scheduled implant procedure 8. Clinically diagnosed hypertrophic obstructive cardiomyopathy, constrictive pericarditis or other infiltrative cardiomyopathy (eg, hemochromatosis, sarcoidosis) 9. Has renal insufficiency as determined by creatinine (S-Cr) level > 2.5 mg/dL or estimated-GFR < 25ml/min/1.73 m2 by CKD-Epi equation; or currently requiring dialysis 10. Significant hepatic impairment defined as 3? upper limit of normal of transaminases, total bilirubin, or alkaline phosphatase 11. Right ventricular dysfunction, defined by the site cardiologist as: a. More than mild RV dysfunction as estimated by TTE; OR b. TAPSE <1.4 cm; OR c. RV size ≥ LV size as estimated by TTE; OR d. Echocardiographic or clinical evidence of congestive hepatopathy; 12. Evidence of pulmonary hypertension with PVR >4 Wood units 13. Performance of the 6 minute walk test with a distance <50m OR >600m 14. Subject is contraindicated to receive either dual antiplatelet therapy or warfarin (analogue); or has a documented coagulopathy 15. Known hypersensitivity to anticoagulation therapy or contrast agent, which cannot be adequately medicated 16. Known hypersensitivity to Nickel 17. In the judgment of the investigator, life expectancy <12 months for noncardiovascular reasons 18. In the opinion of the investigator, the subject is not an appropriate candidate for the study 19. Anatomy (tri

Phase

Not Applicable - Describes studies without FDA-defined phases, including studies of devices or behavioral interventions.

Type of Study

Treatment

Location

University of Colorado Hospital

Principal Investigator
Andreas Brieke,  MD

Andreas Brieke, MD

Study ID

Protocol Number: 18-2765

ClinicalTrials.gov: NCT03088033

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