CompletedNot Applicable

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

United States, Canada25 participantsStarted 2020-11-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Men and Women ≥ 18 years of age;
. The patient has severe symptomatic mitral regurgitation meet criteria for the commercially available MitraClip;
. The patient also has documented paroxysmal, persistent, or permanent atrial fibrillation AND The patient meets the WATCHMAN labeling guidelines;
. The patient is eligible for short-term oral anticoagulation therapy with Warfarin or a direct oral anticoagulant;
. The patient or legal representative is able to understand and willing to provide written informed consent to participate in the trial;
. The patient is able and willing to return for required follow-up visits.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

All-cause mortality rate

Timeframe: 45 days post procedure

All-cause mortality rate

Timeframe: 1 Year post procedure

Serious Adverse Events (SAEs)

Timeframe: 45 days post procedure

Serious Adverse Events (SAEs)

Timeframe: 1 Year post procedure

Trial details

NCT IDNCT04494347

SponsorMayo Clinic

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-03-07

View on ClinicalTrials.gov More Nonvalvular Atrial Fibrillation trials