← Back to Search

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
Must not have
The patient is in a hypercoagulable state
Exclude the patient if per medical record documentation the patient meets any of the following criteria: Thrombosis occurring at under 40 years age, Idiopathic or recurrent VTE (venous thromboembolism, Thrombosis at an unusual site (cerebral veins, hepatic veins, renal veins, IVC, mesenteric veins), Family history of VTE or of inherited prothrombotic disorder, recurrence/extension of thrombosis while adequately anti-coagulated
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if it's safe and effective to perform two heart procedures at the same time for patients with atrial fibrillation. One procedure fixes a leaky heart valve without surgery, and the other reduces stroke risk by closing a small part of the heart. This combined approach aims to reduce risks associated with multiple surgeries and anesthesia.

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can take short-term blood thinners like Warfarin.
Select...
I have a type of irregular heartbeat and qualify for a WATCHMAN device.
Select...
I can understand and am willing to sign the consent form.
Select...
I have severe symptoms from mitral valve regurgitation and qualify for MitraClip.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My blood clots more easily than normal.
Select...
I do not have a history of unusual blood clots or a family history of clotting disorders.
Select...
I cannot take blood thinners for a short period.
Select...
I have a severe narrowing of my heart's mitral valve.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
All-cause mortality rate
Serious Adverse Events (SAEs)
Secondary study objectives
SAEs related to the Study devices

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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).

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
MitraClip TMVR (Transcatheter Mitral Valve Repair) and Watchman LAAO (Left Atrial Appendage Occlusion) are advanced treatments for Atrial Fibrillation (AF). MitraClip TMVR works by clipping together a portion of the mitral valve leaflets to reduce mitral regurgitation, which can improve heart function and reduce AF symptoms. Watchman LAAO involves placing a device in the left atrial appendage to prevent blood clots from forming and entering the bloodstream, thereby reducing the risk of stroke. These treatments are crucial for AF patients as they address both the structural heart issues and the risk of thromboembolism, improving overall outcomes and quality of life.
[Treatment of Patients With Atrial Fibrillation: the Search for Optimal Solutions].

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,324 Previous Clinical Trials
3,059,354 Total Patients Enrolled
32 Trials studying Atrial Fibrillation
13,563 Patients Enrolled for Atrial Fibrillation
Mohamad Adnan (Mohamad) Alkhouli, MDPrincipal InvestigatorMayo Clinic
~6 spots leftby Jan 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top