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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

All-cause death

Cardiac Tamponade

Device related re-intervention or surgery

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 Intervention

V-Wave Shunt Placement

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor

1,030 Previous Clinical Trials

1,364,008 Total Patients Enrolled

samir kapadiaLead Sponsor

1 Previous Clinical Trials

349 Total Patients Enrolled

V-Wave LtdIndustry Sponsor

4 Previous Clinical Trials

641 Total Patients Enrolled

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities available for prospective participants in this experiment?

"Affirmative. Clinicaltrials.gov indicates that this medical experiment is still open for participation, having first been posted on November 3rd 2021 and most recently updated on April 3rd 2022. The researchers are searching for 10 volunteers to be recruited from a single site location."

Answered by AI

How many individuals is this clinical experiment recruiting?

"Affirmative. Data hosted on clinicaltrials.gov confirms that this therapeutic trial, which was initially posted on March 11th 2021, is actively recruiting volunteers. A total of 10 individuals need to be sourced from 1 medical facilities for the study's completion."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Implantation of a Permanent Interatrial Shunt to Reduce Left Atrial Filling Pressures Following MitraClip

samir kapadia 2021. "Implantation of a Permanent Interatrial Shunt to Reduce Left Atrial Filling Pressures Following MitraClip". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04729933.

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