RecruitingNot ApplicableNCT04494347

Watchman for Patients With Atrial Fibrillation Undergoing Transcatheter Mitral Valve Repair (WATCH-TMVR)


Sponsor

Mayo Clinic

Enrollment

25 participants

Start Date

Nov 1, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

WATCH-TMVR (Watchman for Patients with Atrial Fibrillation Undergoing Transcatheter Mitral Valve) Clinical Trial have the main objective to assess the feasibility of combining clinically indicated MitraClip TMVR and Watchman LAAO in one setting.Mayo Clinic will be the data coordinating center for this trial, which will include up to 3 sites.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study examines patients who have both severe mitral valve regurgitation (a leaky heart valve) AND atrial fibrillation (an irregular heart rhythm), and who are undergoing a minimally invasive procedure to repair the valve (MitraClip). It tests whether adding a left atrial appendage closure device (WATCHMAN) during the same procedure reduces the risk of stroke. **You may be eligible if...** - You are 18 or older with severe symptomatic mitral regurgitation meeting criteria for MitraClip - You also have documented atrial fibrillation and meet criteria for the WATCHMAN device - You are eligible for short-term anticoagulation therapy - You are willing and able to attend required follow-up visits **You may NOT be eligible if...** - Your mitral valve anatomy is not suitable for the MitraClip procedure - You cannot tolerate anticoagulation - You have active infection or other significant cardiac conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREMitraClip TMVR and Watchman LAAO

The MitraClip device is a percutaneous edge-to-edge repair device that is intended to approximate the anterior and posterior mitral valve leaflets in patients with severe symptomatic mitral regurgitation with suitable anatomy. Device versions/types: MitraClip NTr, MitraClip XTr. The WATCHMAN device is a self-expanding left atrial appendage occlusion (LAAO) device with a porous covering on the proximal face. Device sizes: 21 mm, 24 mm, 27 mm, 30 mm, 33 mm.


Locations(2)

Mayo Clinic

Rochester, Minnesota, United States

Ottawa Heart Institute

Ottawa, Ontario, Canada

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NCT04494347


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