WATCHMAN FLX Device for Atrial Fibrillation

(CHAMPION-AF Trial)

Recruiting at 154 trial locations

Overseen By William Spear, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston Scientific Corporation

Must be taking: Non-vitamin K anticoagulants

Must not be taking: Anticoagulants, Aspirin, P2Y12 inhibitors

Disqualifiers: Active bleed, Recent stroke, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 36 months

3000 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary objective of this study is to determine if left atrial appendage closure (LAAC) with the WATCHMAN FLX device is a reasonable alternative to non-vitamin K oral anticoagulants in patients with non-valvular atrial fibrillation.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you require long-term anticoagulation therapy for reasons other than atrial fibrillation, you may not be eligible to discontinue those medications.

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

The WATCHMAN FLX is a unique device designed for closing the left atrial appendage in patients with atrial fibrillation, offering an alternative to blood-thinning medications for those at high risk of bleeding. It features improved design elements like higher conformability and a closed distal 'flex-ball' for better fit and safety, making it suitable for patients with complex heart anatomies. ^{1 2 3 4 5}

Research Team

Saibal Kar, MD

Principal Investigator

HCA Healthhcare /Los Robles Health System

Shephal Doshi, MD

Principal Investigator

Pacific Heart Institute and Providence St. John's Health Center

Marty Leon, MD

Principal Investigator

New York-Presbyterian Heart Valve Center/Columbia University Irving Medical Center

Kenneth A Ellenbogen, MD

Principal Investigator

Virginia Commonwealth University

Eligibility Criteria

This trial is for adults with non-valvular atrial fibrillation who can attend follow-up visits and are suitable for certain drug regimens. They must have a CHA2DS2-VASc score of at least 2 (men) or 3 (women). Exclusions include those needing long-term anticoagulation for other reasons, recent stroke/TIA, active infections, known procedure contraindications, allergies to oral anticoagulants/aspirin, planned surgeries around the implant time, and women who are or may become pregnant.

Inclusion Criteria

I am considered fit for the treatment plans in this study.

I can and will come back for all needed follow-ups and tests.

I am legally old enough to participate in this study according to my local laws.

Exclusion Criteria

I have a tumor in my heart.

I need long-term blood thinners for reasons not related to preventing stroke from atrial fibrillation.

I currently have an infection.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either the WATCHMAN FLX device or a non-vitamin K oral anticoagulant

36 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Treatment Details

Interventions

• Non-Vitamin K Oral Anticoagulant
• WATCHMAN FLX LAAC Device

Trial Overview The CHAMPION-AF Clinical Trial is testing if the WATCHMAN FLX device to close the left atrial appendage is as effective as non-vitamin K oral anticoagulants in preventing strokes in patients with atrial fibrillation without heart valve issues.

Participant Groups

Group I: Device Group Experimental Treatment 1 Intervention

Randomized to WATCHMAN FLX Left Atrial Appendage Closure Device

Group II: Control Group Active Control 1 Intervention

Randomized to non-vitamin K oral anticoagulant (NOAC)

Who Is Running the Clinical Trial?

Boston Scientific Corporation

Lead 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

Findings from Research

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 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]

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 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]

References

1. 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]

2. 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]

3. Netherlands pubmed.ncbi.nlm.nih.gov

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

4. England 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. [2023]

5. Ireland pubmed.ncbi.nlm.nih.gov

Impact of operatoŕs experience on peri-procedural outcomes with Watchman FLX: Insights from the FLX-SPA registry. [2023]