WATCHMAN Device for Atrial Fibrillation

(LAAOS-4 Trial)

Recruiting at 90 trial locations

Overseen By Andrea Natale, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Hamilton Health Sciences Corporation

Must be taking: Oral anticoagulants

Must not be taking: Direct thrombin inhibitors

Disqualifiers: Age < 18, Thrombus, Prior occlusion, 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: Procedure duration and immediate recovery

4000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a device called the WATCHMAN to determine its effectiveness in preventing strokes or blood clots in people with atrial fibrillation (an irregular heartbeat). The research aims to assist those who remain at high risk for stroke despite taking blood-thinning medication. Participants will either receive the WATCHMAN device or continue with their usual medical care. Individuals with atrial fibrillation who have experienced a stroke or blood clot, despite taking blood thinners for at least three months, might be a good fit. As an unphased trial, this study offers a unique opportunity to contribute to medical research and potentially benefit from innovative treatment options.

Will I have to stop taking my current medications?

The trial requires participants to continue taking their current oral anticoagulant medications (like Vitamin K agonists or factor Xa inhibitors) for the duration of the study.

What prior data suggests that the WATCHMAN device is safe for atrial fibrillation patients?

Research has shown that the WATCHMAN device is safe for patients. In earlier studies, the WATCHMAN FLX, a version of the device, demonstrated a very low rate of major problems during the procedure. Only about 0.37% of patients experienced significant issues within the first week or before leaving the hospital. Another study found a slightly higher rate of 0.45%, but this remains low. These results suggest that most people tolerate the device well. The WATCHMAN device is designed to help prevent strokes in people with atrial fibrillation, a type of irregular heartbeat. Overall, the evidence supports its safety for those needing this kind of heart protection. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The WATCHMAN device is unique because it offers a non-pharmaceutical approach to managing atrial fibrillation, specifically targeting the left atrial appendage to prevent strokes. Unlike standard treatments like blood thinners, which can increase bleeding risk, the WATCHMAN device physically blocks the appendage, reducing stroke risk without the need for long-term medication. Researchers are excited because this device could provide a safer, long-lasting solution for patients who cannot use traditional blood thinners effectively.

What evidence suggests that the WATCHMAN device is effective for preventing stroke in atrial fibrillation?

Research has shown that the WATCHMAN device, which participants in this trial may receive, helps prevent strokes in people with atrial fibrillation (AF). One study found that the WATCHMAN is as effective as blood thinners in preventing blood clots, but with fewer safety issues. In real-world data from over 97,000 patients, doctors successfully implanted the device in 98% of cases. Another study reported a 100% success rate for the procedure with no major complications. This device offers an alternative to long-term use of blood thinners, reducing the risk of stroke in AF patients. Participants in this trial will either undergo endovascular left atrial appendage occlusion with the WATCHMAN device or receive local, standard medical care. ^{2 6 7 8 9}

Who Is on the Research Team?

Jeff S Healey, MD

Principal Investigator

Hamilton Health Sciences Corporation

Are You a Good Fit for This Trial?

This trial is for adults with atrial fibrillation who are at high risk of stroke, even while on blood thinners. They should have a CHA2DS2-VASc score of 4 or more, indicating they're more likely to have a stroke. Participants must be willing to continue their current oral anticoagulant therapy throughout the study.

Inclusion Criteria

You have a heightened risk of stroke, determined via the CHA2DS2-VASc score being equal to or greater than four.

I have ongoing or occasional atrial fibrillation and have had a stroke or blood clot.

I have been on blood thinners for at least 3 months and plan to continue.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo endovascular left atrial appendage occlusion with the WATCHMAN device or receive standard medical care

Procedure duration and immediate recovery

1 visit (in-person for procedure)

Follow-up

Participants are monitored for safety and effectiveness, including assessment of ischemic stroke or systemic embolism

4 years

Regular follow-up visits (frequency not specified)

What Are the Treatments Tested in This Trial?

Interventions

• WATCHMAN device

Trial Overview The LAAOS-4 study tests if using the WATCHMAN device can prevent strokes or blood clots in people with atrial fibrillation who still face high stroke risks despite taking blood thinners. The device is implanted through a catheter-based procedure.

How Is the Trial Designed?

Group I: WATCHMAN device Experimental Treatment 1 Intervention

Participants will undergo endovascular left atrial appendage occlusion with the WATCHMAN device

Group II: Standard Care Active Control 1 Intervention

Participants will receive local, standard medical care

Who Is Running the Clinical Trial?

Hamilton Health Sciences Corporation

Lead Sponsor

Trials

380

Recruited

345,000+

McMaster University

Collaborator

Trials

936

Recruited

2,630,000+

Population Health Research Institute

Collaborator

Trials

165

Recruited

717,000+

Boston Scientific Corporation

Industry Sponsor

Trials

758

Recruited

867,000+

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology

Published Research Related to This Trial

The WATCHMAN device offers a promising alternative to long-term warfarin therapy for patients with atrial fibrillation (AF) who are at high risk for embolic events but may face complications from anticoagulants, supported by medium-term efficacy and safety data.

This review highlights important technical aspects of WATCHMAN implantation, emphasizing its role as a well-studied option for nonvalvular AF patients who require oral anticoagulation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Watchman Device: Left Atrial Appendage Closure For Stroke Prophylaxis In Atrial Fibrillation. N Obeyesekere Mbbs Mrcp Fracp Fhrs, DM.[2020]

In a study of 169 patients undergoing left atrial appendage closure, the WATCHMAN FLX device showed significant improvements over the WATCHMAN V.2.5, particularly in reducing peridevice leakage and adverse clinical events after 3 months.

The WM FLX device demonstrated continued expansion and reduced device compression over time, which correlated with a lower incidence of complications such as stroke and device-related thrombosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transition from WATCHMAN V.2.5 to WATCHMAN FLX for closure of the left atrial appendage: echocardiographic and clinical findings. Sakriss, C., Roehl, P., Schwenzky, A., et al.[2023]

The Watchman FLX left atrial appendage closure device was successfully implanted in 30 patients using intracardiac echocardiography (ICE), achieving a 100% technical success rate without any procedure-related complications.

Follow-up imaging at about 47 days showed that the device was effective, with no device-related thrombus or significant leaks, indicating its safety and efficacy for patients with atrial fibrillation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intracardiac echocardiography-guided implantation of the Watchman FLX left atrial appendage closure device. Turagam, MK., Neuzil, P., Petru, J., et al.[2021]

In a study analyzing 43,802 Watchman LAAC device implants from March 2015 to March 2019, the overall adverse event rate was found to be 7.3%, with a low mortality rate of 0.4%.

Most adverse events occurred either during the procedure or within the first day, but a notable percentage of serious complications, including device embolizations and strokes, happened more than a month after implantation, highlighting the need for ongoing monitoring post-procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MAUDE Database Analysis of Post-Approval Outcomes following Left Atrial Appendage Closure with the Watchman Device. Ledesma, PA., Uzomah, UA., Yu, X., et al.[2021]

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]

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 operato&#341;s 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 left atrial appendage closure device is designed to reduce the risk of stroke in patients with nonvalvular atrial fibrillation, but initial studies raised safety concerns leading to a 'not approvable' status from the FDA.

In the subsequent PREVAIL trial, while the device was eventually deemed to have benefits that outweigh risks, updated data indicated a higher incidence of ischemic strokes in the WATCHMAN group (13 strokes) compared to the control group (1 stroke), prompting further review of its safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overview of the Food and Drug Administration circulatory system devices panel meetings on WATCHMAN left atrial appendage closure therapy. Waksman, R., Pendyala, LK.[2015]

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]

Citations

1. watchman.com watchman.com/en-us-hcp/clinical-evidence/surpass-one-year-results.html

SURPASS real-world data SURPASS data reinforces the WATCHMAN FLX Implant procedural success with 98% of patients implanted (N=97,185)1 across nearly all anatomies in a real-world ...

2. watchman.com watchman.com/en-us-implanter/clinical-evidence/option.html

OPTION Clinical Trial - Design, Outcomes - WATCHMAN FLX The primary endpoints showed WATCHMAN FLX™ was equally effective to anticoagulation, with a superior safety profile, which allowed patients to eliminate ...

3. bostonscientific.com bostonscientific.com/en-EU/products/laac-system/watchman-flx/clinical-evidence.html

Clinical Evidence This data reinforces the outstanding safety of WATCHMAN FLX with 0.37% major procedural adverse event rate within 7 days or hospital discharge and 98% ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40696744/

Evaluating the New Watchman FLX Pro 40 mm Device Results: The study demonstrated a 100% procedural success rate, with all patients undergoing same-day discharge. No procedural or periprocedural ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11008520/

Percutaneous left atrial appendage closure with the ... LAAC with Watchman device implantation is an alternative method to anticoagulation therapy in order to prevent thromboembolic complications in patients with AF.

6. watchman.com watchman.com/en-us-implanter/clinical-evidence.html

Clinical Evidence - Studies and Trials - WATCHMAN FLX The OPTION clinical trial is the first randomized, head-to-head study comparing left atrial appendage closure (LAAC) to oral anticoagulants (OACs)—95% of ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10658049/

Efficacy and safety of the new generation Watchman FLX ... The W-FLX was associated with a higher procedural success rate and significantly reduced adverse outcomes including mortality, major bleeding, device ...

8. watchman.com watchman.com/en-us-implanter/clinical-evidence/surpass-one-year-results.html

SURPASS One-Year Results - Study Design The SURPASS one-year outcomes analysis reported a 0.45% major procedural adverse event rate within seven days or at hospital discharge.

9. jacc.org jacc.org/doi/10.1016/j.jacadv.2024.101377

Outcomes of Concomitant Atrial Fibrillation Ablation and ... A total of 102 patients (57.3%) underwent LAAC with the legacy WATCHMAN device, and 76 patients (42.7%) with the WATCHMAN FLX device. Of the ...