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Interatrial Shunt

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am eligible for a MitraClip procedure for my heart valve issue.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have severe heart or lung conditions, recent major heart procedures, or a life expectancy under 1 year due to non-cardiac conditions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 months, 1 year, 2 years, 3 years and 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 months, 1 year, 2 years, 3 years and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
All-cause death
Cardiac Tamponade
Device related re-intervention or surgery
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
V-Wave Shunt Placement

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor
1,057 Previous Clinical Trials
1,371,462 Total Patients Enrolled
samir kapadiaLead Sponsor
1 Previous Clinical Trials
350 Total Patients Enrolled
V-Wave LtdIndustry Sponsor
4 Previous Clinical Trials
641 Total Patients Enrolled
Samir Kapadia, M. D.Principal Investigator - The Cleveland Clinic
Cleveland Clinic Hospital
N H L Municipal Medical College (Medical School)
Cleveland Clinic Fndn (Residency)

Media Library

V-Wave Shunt Placement (Interatrial Shunt) Clinical Trial Eligibility Overview. Trial Name: NCT04729933 — N/A
Mitral Valve Regurgitation Research Study Groups: Treatment
Mitral Valve Regurgitation Clinical Trial 2023: V-Wave Shunt Placement Highlights & Side Effects. Trial Name: NCT04729933 — N/A
V-Wave Shunt Placement (Interatrial Shunt) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04729933 — N/A
~4 spots leftby Dec 2027
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