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Device

Watchman for Atrial Fibrillation (WATCH-TMVR Trial)

N/A

Recruiting

Led By Mohamad Adnan (Mohamad) Alkhouli, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

The patient is eligible for short-term oral anticoagulation therapy with Warfarin or a direct oral anticoagulant

The patient also has documented paroxysmal, persistent, or permanent atrial fibrillation AND The patient meets the WATCHMAN labeling guidelines

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

WATCH-TMVR Trial Summary

This trial will assess the feasibility of combining two procedures to treat atrial fibrillation. Mayo Clinic will coordinate the trial, which will include up to 3 sites.

Who is the study for?

This trial is for adults over 18 with severe symptomatic mitral regurgitation who qualify for MitraClip treatment and have atrial fibrillation fitting the WATCHMAN guidelines. Participants must be able to attend follow-ups, understand and consent to the study, and can take short-term oral anticoagulants.Check my eligibility

What is being tested?

The WATCH-TMVR trial tests if it's feasible to combine MitraClip TMVR (a procedure for mitral valve repair) with Watchman LAAO (a device that closes off a part of the heart) in one session for patients with both mitral regurgitation and atrial fibrillation.See study design

What are the potential side effects?

Potential side effects may include complications from heart procedures like bleeding or infection, reactions related to the devices such as clot formation or device dislocation, and general risks associated with anesthesia.

WATCH-TMVR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take short-term blood thinners like Warfarin.

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I have a type of irregular heartbeat and qualify for a WATCHMAN device.

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I can understand and am willing to sign the consent form.

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I have severe symptoms from mitral valve regurgitation and qualify for MitraClip.

WATCH-TMVR Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

All-cause mortality rate

Serious Adverse Events (SAEs)

Secondary outcome measures

SAEs related to the Study devices

WATCH-TMVR Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment GroupExperimental Treatment1 Intervention

This is not a randomized study. Patients who are clinically indicated for both procedures will be offered the option to enroll in this registry for a combined procedure. Otherwise, they will undergo TMVr and LAAO in two separate session as clinically indicated (standard of care).

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,212 Previous Clinical Trials

3,767,013 Total Patients Enrolled

32 Trials studying Atrial Fibrillation

13,563 Patients Enrolled for Atrial Fibrillation

Mohamad Adnan (Mohamad) Alkhouli, MDPrincipal InvestigatorMayo Clinic

Frequently Asked Questions

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

Is this research endeavor currently open to enrollment?

"According to clinicialtrials.gov, this investigation is still in search of participants and was first publicized on November 1st 2020 with the most recent update occurring on October 12th 2022."

Answered by AI

How many people are enrolled in this research project?

"Right. According to the information found on clinicaltrials.gov, this investigation is still actively seeking participants. It was first announced in November 1st 2020 and most recently modified 10/12/2022. Currently, 25 patients must be registered across 2 distinct medical centres"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Mohamad Adnan Alkhouli 2020. "Watchman for Patients With Atrial Fibrillation Undergoing Transcatheter Mitral Valve Repair (WATCH-TMVR)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04494347.