Active, not recruitingNCT04729933

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

samir kapadiaOne US siteView on ClinicalTrials.gov

AI Description

This is an investigator initiated, prospective study to demonstrate the safety and feasibility of implantation of the V-Wave Interatrial Shunt System (herein called the "V-Wave Shunt" in patients immediately following percutaneous mitral valve repair using the MitraClip system.

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Who can join
adult, older adult
Participants
16
Expected completion
2030-12-31
Funded by
other

Conditions studied

Heart Failure, Mitral Regurgitation

What is being tested

  • DEVICE: V-Wave Shunt Placement

What it measures

  • Number of Occurrence for Device-related Major Adverse Cardiovascular and Neurologic Events (MACNE), Number occurrence for Device-related Major Adverse Cardiovascular and Neurologic Events (MACNE) defined as: * All cause death * Stroke and paradoxical embolism * Myocardial infarction * V-Wave shunt device embolization * Cardiac tamponade * Device related re-intervention or surgery, Up to1 month post implant

Working with

V-Wave Ltd

Centers Participating

These centers are participating in this study. Reach out to them directly to learn more.

Cleveland Clinic

Cleveland, OH

Data Sources and Methodology

Registry entry updated 2026-08-05

Deciding whether to join a study is your choice, and you can ask a study team questions before you decide anything.

If you would rather we did it with you, call us on (656) 206-4686.

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