Watchman for Atrial Fibrillation

(WATCH-TMVR Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Mohamad Adnan (Mohamad) Alkhouli, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Mayo Clinic

Must be taking: Oral anticoagulants

Must not be taking: Long-term warfarin

Disqualifiers: Mitral stenosis, Thrombus, Pregnancy, others

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but you must be eligible for short-term oral anticoagulation therapy with Warfarin or a direct oral anticoagulant. If you require long-term warfarin therapy for certain conditions, you may not be eligible to participate.

What data supports the effectiveness of the treatment Watchman for Atrial Fibrillation?

The Watchman FLX device, used for closing the left atrial appendage (a small pouch in the heart), has shown good success and safety in small studies and real-world experiences, suggesting it can effectively reduce the risk of stroke in patients with atrial fibrillation who cannot take blood thinners.

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Is the Watchman device safe for humans?

The Watchman FLX device has shown good safety in small studies and real-world experiences, with improvements in design for better performance and safety. It is used as an alternative to blood thinners for patients with atrial fibrillation, and studies suggest it is generally safe for humans.

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How is the Watchman FLX treatment for atrial fibrillation different from other treatments?

The Watchman FLX is a unique device for closing the left atrial appendage (a small pouch in the heart) to reduce stroke risk in patients with atrial fibrillation who cannot take blood thinners. It is designed to fit a wider range of heart shapes and offers a safer, more effective alternative to long-term medication.

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Eligibility Criteria

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.

Inclusion Criteria

I can take short-term blood thinners like Warfarin.

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

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

Exclusion Criteria

My blood clots more easily than normal.

I need long-term warfarin because of a past blood clot.

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

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a combined procedure of MitraClip TMVR and Watchman LAAO

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

1 year

Regular follow-up visits as per clinical protocol

Participant Groups

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.

Group I: Treatment Group Experimental Treatment 1 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).

MitraClip TMVR and Watchman LAAO is already approved in United States, European Union, United States, European Union for the following indications:

🇺🇸 Approved in United States as Watchman FLX for:

• Non-valvular atrial fibrillation to reduce the risk of thromboembolism from the left atrial appendage

🇪🇺 Approved in European Union as Watchman FLX for:

• Non-valvular atrial fibrillation to reduce the risk of thromboembolism from the left atrial appendage

🇺🇸 Approved in United States as MitraClip TMVR for:

• Mitral regurgitation in patients who are at high surgical risk for mitral valve surgery

🇪🇺 Approved in European Union as MitraClip TMVR for:

• Mitral regurgitation in patients who are at high surgical risk for mitral valve surgery

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Mayo Clinic Rochester, MN

Ottawa Heart Institute Ottawa, Canada

Who Is Running the Clinical Trial?

Mayo Clinic Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

Real-world experience with the new Watchman FLX device: Data from two high-volume Sicilian centers. The FLX-iEST registry. [2022] The Watchman-FLX left atrial appendage closure (LAAC) device presents innovative features: higher conformability, reduced length, closed distal "flex-ball" during deployment, and flattened surface. We report our real-world experience with the Watchman-FLX device in two centers with consolidated LAAC expertise.

2. United States pubmed.ncbi.nlm.nih.gov

Primary Outcome Evaluation of a Next-Generation Left Atrial Appendage Closure Device: Results From the PINNACLE FLX Trial. [2023] Left atrial appendage (LAA) occlusion provides an alternative to oral anticoagulation for thromboembolic risk reduction in patients with nonvalvular atrial fibrillation. Since regulatory approval in 2015, the WATCHMAN device has been the only LAA closure device available for clinical use in the United States. The PINNACLE FLX study (Protection Against Embolism for Nonvalvular AF Patients: Investigational Device Evaluation of the Watchman FLX LAA Closure Technology) evaluated the safety and effectiveness of the next-generation WATCHMAN FLX LAA closure device in patients with nonvalvular atrial fibrillation in whom oral anticoagulation is indicated, but who have an appropriate rationale to seek a nonpharmaceutical alternative.

3. Ireland pubmed.ncbi.nlm.nih.gov

Impact of operatoŕs experience on peri-procedural outcomes with Watchman FLX: Insights from the FLX-SPA registry. [2023] Label="BACKGROUND" NlmCategory="BACKGROUND">The Watchman FLX is a device upgrade of the Watchman 2.5 that incorporates several design enhancements intended to simplify left atrial appendage occlusion (LAAO) and improve procedural outcomes. This study compares peri-procedural results of LAAO with Watchman FLX (Boston Scientific, Marlborough, Massachusetts) in centers with varying degrees of experience with the Watchman 2.5 and Watchman FLX.

4. Switzerland pubmed.ncbi.nlm.nih.gov

Periprocedural outcome in patients undergoing left atrial appendage occlusion with the Watchman FLX device: The ITALIAN-FLX registry. [2023] The Watchman FLX is a novel device for transcatheter left atrial appendage occlusion (LAAO) specifically designed to improve procedural performance in more complex anatomies with a better safety profile. Recently, small prospective non-randomized studies have shown good procedural success and safety compared with previous experiences. Results from large multicenter registries are needed to confirm the safety and efficacy of the Watchman FLX device in a real-world setting.

5. England pubmed.ncbi.nlm.nih.gov

Left atrial appendage closure device implantation via transhepatic vascular access: a case report. [2022] In patients with non-valvular atrial fibrillation, an estimated 90% of thrombi are located in the left atrial appendage. The WATCHMAN device is a left atrial appendage closure device that is an alternative therapeutic option to reduce the risk of systemic embolization in patients who are intolerant of long-term oral anticoagulation. It can be deployed in the left atrial appendage using a transseptal approach via the femoral vein. Transhepatic venous access is an alternative route for the delivery of the device in a patient with difficult vascular access.

6. Netherlands pubmed.ncbi.nlm.nih.gov

Initial experience with the WATCHMAN™ left atrial appendage system for stroke prevention in atrial fibrillation: A single-centre registry. [2017] Left atrial appendage (LAA) closure using the WATCHMAN™ device (WM) may be considered in patients with non-valvular atrial fibrillation (AF) and a high-risk of stroke who are ineligible for long-term oral anticoagulation (OAC).

7. Netherlands pubmed.ncbi.nlm.nih.gov

Watchman FLX Implantation for Challenging Left Atrial Appendage Anatomy: Case-Based Discussion. [2022] Left atrial appendage (LAA) occlusion devices provided an acceptable and valid alternative to anticoagulation among patients with atrial fibrillation who carry high bleeding risk. Watchman device is non-inferior to oral anticoagulation to prevent cerebrovascular accidents. The presence of a longer distal portion of the older generation Watchman led to exclusion of patients with prohibitive anatomy of the LAA such as chicken-wing morphology or shallow LAA. Watchman FLX provides a wider range of sizes and can be implanted with complex anatomy or shallow LAA. In the case series, we discuss 3 patients with challenging LAA anatomy that underwent successful Watchman FLX implantation.