What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for atrial fibrillation (AF) include antiarrhythmic drugs and procedures like the MitraClip TMVR and Watchman LAAO. Antiarrhythmic drugs such as amiodarone, sotalol, and dofetilide can cause serious side effects including proarrhythmia, bradycardia, and extracardiac issues like thyroid dysfunction and pulmonary toxicity. The Watchman device, used for left atrial appendage occlusion, reduces stroke risk but carries procedural risks such as pericardial effusion and device-related thrombus. The MitraClip procedure for mitral valve repair can result in complications like bleeding, infection, and device malfunction.

What prior FDA approvals exist?

The FDA has approved the Watchman device for left atrial appendage occlusion (LAAO) based on trials like PROTECT AF and PREVAIL, which showed its effectiveness in reducing stroke risk in atrial fibrillation (AF) patients unsuitable for long-term anticoagulation. Additionally, the MitraClip for transcatheter mitral valve repair (TMVR) is approved for treating mitral regurgitation, often associated with AF. These devices provide mechanical alternatives to anticoagulants such as warfarin and direct oral anticoagulants (DOACs), aiming to lower thromboembolic risk in AF patients.

What other types of research exist?

Promising novel alternatives to MitraClip TMVR and Watchman LAAO for AF patients include the AMPLATZER™ device for left atrial appendage occlusion and the LARIAT™ device, which offers an epicardial approach for LAA closure. These devices provide different mechanisms and approaches for stroke prevention in AF patients, potentially offering tailored options based on individual patient needs and anatomical considerations.

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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

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

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My blood clots more easily than normal.

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I do not have a history of unusual blood clots or a family history of clotting disorders.

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I cannot take blood thinners for a short period.

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I have a severe narrowing of my heart's mitral valve.

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

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).

0 / 8Eligibility criteria met

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].