Watchman for Atrial Fibrillation

(WATCH-TMVR Trial)

Recruiting at 1 trial 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. ^{1 2 3 4 5}

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. ^{1 2 4 5 6}

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. ^{1 2 4 5 7}

Research Team

Mohamad Adnan (Mohamad) Alkhouli, MD

Principal Investigator

Mayo Clinic

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

Treatment Details

Interventions

• MitraClip TMVR and Watchman LAAO (Device)

Trial Overview 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.

Participant Groups

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).

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

The Watchman-FLX left atrial appendage closure device demonstrated a high procedural success rate of 99.5% in a high-risk population of 200 patients, with no reported device embolizations and a low complication rate of 8.5%.

Key advantages of the Watchman-FLX include its ease of implantation and repositioning, effective sealing of the left atrial appendage, and a significantly lower failure rate compared to the first-generation Watchman device.

NCBI (Pubmed)

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. Vizzari, G., Grasso, C., Sardone, A., et al.[2022]

The WATCHMAN FLX LAA closure device demonstrated a very low incidence of serious adverse events (0.5%) in a study of 400 patients, significantly below the performance goal of 4.2%, indicating a high level of safety for patients seeking alternatives to anticoagulation therapy.

The device achieved a 100% effectiveness rate in closing the left atrial appendage, surpassing the performance goal of 97.0%, which suggests it is highly effective in reducing thromboembolic risk in patients with nonvalvular atrial fibrillation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary Outcome Evaluation of a Next-Generation Left Atrial Appendage Closure Device: Results From the PINNACLE FLX Trial. Kar, S., Doshi, SK., Sadhu, A., et al.[2023]

The Watchman FLX device achieved a high procedural success rate of 98.6% for left atrial appendage occlusion (LAAO) in a study involving 359 patients across 26 centers, demonstrating its effectiveness in real-world settings.

The procedure had a low incidence of major peri-procedural complications at only 2.5%, indicating that the Watchman FLX is a safe option for LAAO, regardless of the operator's prior experience with the previous Watchman 2.5 device.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of operatoŕs experience on peri-procedural outcomes with Watchman FLX: Insights from the FLX-SPA registry. Cruz-González, I., Torres Saura, F., Trejo-Velasco, B., et al.[2023]

The Watchman FLX device achieved a remarkable technical success rate of 100% in a study of 772 patients undergoing left atrial appendage occlusion, indicating its effectiveness in real-world settings.

The procedure had a low incidence of major adverse events, with only 2.7% of patients experiencing complications, primarily major extracranial bleeding, showcasing a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Periprocedural outcome in patients undergoing left atrial appendage occlusion with the Watchman FLX device: The ITALIAN-FLX registry. Berti, S., De Caterina, AR., Grasso, C., et al.[2023]

The WATCHMAN device is an effective alternative for patients with non-valvular atrial fibrillation who cannot tolerate long-term anticoagulation, as it reduces the risk of blood clots originating from the left atrial appendage.

In a case involving an 81-year-old man with difficult vascular access, the WATCHMAN device was successfully implanted using a transhepatic approach, demonstrating that this method is a safe and viable option for patients with obstructed femoral veins.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Left atrial appendage closure device implantation via transhepatic vascular access: a case report. Zare, P., Rechani, L., Smithson, S.[2022]

In a study of 23 patients with non-valvular atrial fibrillation, the WATCHMAN™ device implantation showed a high procedural success rate of 95.7%, indicating that the procedure is feasible and effective for stroke prevention in patients who cannot use long-term anticoagulation.

No adverse events occurred during hospitalization or within 45 days post-procedure, demonstrating the safety of the WATCHMAN™ device implantation when performed by trained operators.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial experience with the WATCHMAN™ left atrial appendage system for stroke prevention in atrial fibrillation: A single-centre registry. Bonnet, G., Salaun, E., Pankert, M., et al.[2017]

The Watchman FLX device is a safe and effective alternative to anticoagulation for patients with atrial fibrillation at high risk of bleeding, showing non-inferiority in preventing strokes.

Unlike its predecessor, the Watchman FLX can accommodate a wider range of anatomical variations in the left atrial appendage, making it suitable for patients with challenging anatomies, as demonstrated in a case series of three successful implantations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Watchman FLX Implantation for Challenging Left Atrial Appendage Anatomy: Case-Based Discussion. Joury, A., Englert, JAR., Bernard, M., et al.[2022]

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]

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]

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]

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]

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

Left atrial appendage closure device implantation via transhepatic vascular access: a case report. [2022]

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]

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

Watchman FLX Implantation for Challenging Left Atrial Appendage Anatomy: Case-Based Discussion. [2022]