Watchman for Atrial Fibrillation

(WATCH-TMVR Trial)

Recruiting at 1 trial location

Overseen By Mohamad Adnan (Mohamad) Alkhouli, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must be taking: Oral anticoagulants

Must not be taking: Long-term warfarin

Disqualifiers: Mitral stenosis, Thrombus, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach for people with atrial fibrillation (irregular heartbeat) and severe mitral regurgitation (heart valve leakage). It aims to determine if two procedures—MitraClip TMVR, which repairs the leaking heart valve, and Watchman LAAO (Left Atrial Appendage Closure Device), which helps prevent strokes—can be safely performed together. Patients with both heart issues who can take short-term blood thinners and have been diagnosed with atrial fibrillation might be suitable candidates. As an unphased trial, this study offers patients the chance to contribute to innovative research that could enhance future treatment options.

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 prior data suggests that this device is safe for patients with atrial fibrillation?

Research has shown that the Watchman device, used to block the left atrial appendage of the heart, is quite safe for patients. In a large study, 97.5% of patients successfully received the implant, and only 0.37% experienced major complications shortly after the procedure. This indicates that most people tolerate the device well.

For the MitraClip, which repairs the heart's mitral valve without surgery, long-term studies have indicated it is generally safe. Over five years, patients with this treatment had fewer hospital visits for heart failure and lower overall death rates. However, those with atrial fibrillation might face higher risks for hospital visits and death compared to those without it.

Both treatments have undergone thorough study and received FDA approval for their specific uses, supporting their safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Watchman LAAO and MitraClip TMVR treatments for atrial fibrillation because they offer a unique dual approach to managing the condition. The Watchman device is designed to prevent stroke by closing off the left atrial appendage, where dangerous blood clots often form in atrial fibrillation patients. Meanwhile, the MitraClip provides a minimally invasive option to repair the mitral valve, addressing heart function issues without the need for open-heart surgery. This combination could enhance patient outcomes by simultaneously tackling multiple heart-related concerns with less invasive procedures compared to traditional surgical methods.

What evidence suggests that the MitraClip TMVR and Watchman LAAO are effective for atrial fibrillation?

Studies have shown that the MitraClip procedure effectively repairs the mitral valve, achieving a high success rate of 92% and significantly improving heart function. However, patients with atrial fibrillation (AF) who undergo this procedure may face a higher risk of death and hospitalization due to heart failure. The Watchman device, successfully implanted 97.5% of the time, helps reduce the risk of major health issues and strokes within one year. In this trial, patients clinically indicated for both procedures can enroll for a combined procedure. This combination aims to address both valve repair and stroke risk in patients with AF. Initial research suggests that using these two treatments together could provide comprehensive heart care for those with complex conditions. ^{1 3 6 7 8}

Who Is on the Research Team?

Mohamad Adnan (Mohamad) Alkhouli, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• MitraClip TMVR and Watchman LAAO

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.

How Is the Trial Designed?

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 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

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

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]

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 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]

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-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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37865125

Outcomes of Transcatheter Mitral Valve Repair Using the ... The presence of AF in patients who underwent TMVR with MitraClip is associated with higher all-cause mortality and HF hospitalization.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2474870622002561

Impact of Atrial Fibrillation on the Outcomes after MitraClip Atrial fibrillation (AF) has been associated with worse outcomes in patients undergoing mitral valve surgery for mitral regurgitation.

3. jacc.org jacc.org/doi/10.1016/j.jcin.2018.12.012

The Prevalence and Impact of Atrial Fibrillation on 1-Year ... The aim of this study was to compare 1-year outcomes following transcatheter mitral valve (MV) repair in patients with and without atrial ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10766153/

Transcatheter Mitral Valve Repair with MitraClip The procedural success rate was 92% to achieve mild residual MR. There was no periprocedural death. All patients experienced significant improvement in heart ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002914923010536

Outcomes of Transcatheter Mitral Valve Repair Using the ... The presence of AF in patients who underwent TMVR with MitraClip is associated with higher all-cause mortality and HF hospitalization.

6. sciencedirect.com sciencedirect.com/science/article/pii/S1109966625000764

Atrial fibrillation's role in MitraClip patient outcomes: a ... AF was observed in 46.9% of the patients and was associated with distinct hemodynamic features, including significantly elevated right (11 ...

7. ajconline.org ajconline.org/article/S0002-9149(23)01053-6/abstract

Outcomes of Transcatheter Mitral Valve Repair Using the ... The presence of AF in patients who underwent TMVR with MitraClip is associated with higher all-cause mortality and HF hospitalization. This should be taken into ...

8. nejm.org nejm.org/doi/full/10.1056/NEJMoa2300213

Five-Year Follow-up after Transcatheter Repair ... Transcatheter edge-to-edge repair of the mitral valve was safe and led to a lower rate of hospitalization for heart failure and lower all-cause mortality ...