V-Wave Shunt After MitraClip for Heart Failure

N/A

Recruiting

Led By Samir Kapadia, M. D.

Research Sponsored by The Cleveland Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All patients must meet clinical and anatomic eligibility for commercial placement of MitraClip for functional MR, as specified by the MitraClip Instructions for Use (IFU).

Be older than 18 years old

Must not have

Severe pulmonary hypertension, moderate or severe RV dysfunction, untreated severe (3+ to 4+) tricuspid or pulmonary regurgitation, untreated clinically significant coronary disease requiring revascularization, coronary artery bypass grafting, percutaneous coronary intervention, transcatheter aortic valve implantation, or CRT-D implantation within 30 days, aortic or tricuspid valve requiring surgery or transcatheter intervention, COPD requiring continuous home oxygen therapy or chronic outpatient steroid use, cerebrovascular accident within prior 30 days, known severe symptomatic carotid stenosis, carotid surgery or stenting within prior 30 days, ACC/AHA Stage D heart failure, hypertrophy cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology, infiltrative cardiomyopathy (e.g. amyloidosis, hemochromatosis, sarcoidosis), leaflet anatomy which may preclude MitraClip implantation, hemodynamic instability, need for surgery within 12 months, life expectancy < 1 year due to non-cardiac conditions, status 1 for cardiac transplant or history of cardiac transplant, modified Rankin score ≥ 4 for disability, prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve, or any prior transcatheter mitral valve procedure, echocardiographic evidence of intracardiac mass, thrombus, or vegetation, active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease, active infection requiring antibiotic therapy, TEE is contraindicated or high risk, pregnant or planning pregnancy within 12 months, known hypersensitivity or contraindication to procedural medications that cannot be adequately treated, known allergy to nickel, patient is otherwise not appropriate for the study as determined by the investigator or the Eligibility Committee, for which the reasons must be documented, presence of severe pulmonary hypertension assessed by invasive hemodynamic measurement with pulmonary artery catheterization prior to MitraClip placement, anatomical anomaly on TEE that precludes implantation of the study device across the interatrial communication created by the MitraClip procedure, moderate or worse MR ≥2+ at the end of MitraClip treatment, key hemodynamic exclusions after MitraClip treatment, characteristics of septal defect, patient is otherwise not appropriate for study as determined by the Investigator.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 6 months, 1 year, 2 years, 3 years and 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether a new device, called the V-Wave Shunt, is safe and feasible to implant in patients immediately following percutaneous mitral valve repair using the MitraClip system.

Who is the study for?

This trial is for patients with symptomatic secondary mitral valve regurgitation due to heart issues, who have had at least one hospitalization for heart failure or high BNP levels. They must be eligible for MitraClip therapy and not suitable for mitral valve surgery. Exclusions include severe pulmonary hypertension, recent strokes or surgeries, certain types of cardiomyopathies, active infections, and known allergies to nickel.

What is being tested?

The study tests the safety and feasibility of implanting a V-Wave Interatrial Shunt in patients immediately after they've received a MitraClip procedure. The goal is to see if this shunt can help reduce left atrial filling pressures in these heart failure patients.

What are the potential side effects?

Potential side effects may include complications from the device implantation like bleeding or infection, adverse reactions to materials in the shunt such as nickel allergy symptoms, and possible impact on heart function that could require further medical attention.