WATCHMAN FLX Device for Atrial Fibrillation

(CHAMPION-AF Trial)

Not currently recruiting at 161 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a new device, the WATCHMAN FLX, can serve as a good alternative to certain blood thinners for individuals with atrial fibrillation (AF) not caused by heart valve issues. The trial compares two groups: one using the WATCHMAN FLX device and another continuing with standard blood-thinning medications. It seeks participants with AF who do not have serious related conditions, such as recent strokes, or other major health issues requiring constant blood thinners. Participants must attend follow-up appointments and understand the trial process. As an unphased trial, this study offers a unique opportunity to contribute to medical research and potentially benefit from an innovative treatment option.

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.

What prior data suggests that the WATCHMAN FLX device is safe for left atrial appendage closure?

Research has shown that the WATCHMAN FLX device is very safe. In studies, only about 0.45% to 0.49% of people experienced major issues in the first week after receiving it. This means that out of every 200 people, only about one might encounter a significant problem. Other research indicates that the device works well and is a safe choice for those who cannot take blood thinners. Overall, the WATCHMAN FLX device has a strong safety record and is well-tolerated by most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The WATCHMAN FLX Device is unique because it offers a non-drug solution for reducing the risk of stroke in patients with atrial fibrillation. Unlike traditional treatments that typically rely on blood thinners such as warfarin or non-vitamin K oral anticoagulants (NOACs), the WATCHMAN FLX is a small device implanted in the heart to block the left atrial appendage, which is where blood clots often form. This mechanical approach is particularly exciting for patients who have a high risk of bleeding or those who cannot tolerate long-term blood thinner use. Researchers are enthusiastic about its potential to provide a safer, more effective alternative for stroke prevention in this population.

What evidence suggests that the WATCHMAN FLX device is effective for atrial fibrillation?

Research has shown that the WATCHMAN FLX device effectively closes the left atrial appendage in individuals with non-valvular atrial fibrillation. One study demonstrated that the device successfully closed the left atrial appendage in all patients, with few safety concerns. Another study found that the WATCHMAN FLX had a high success rate during the procedure and fewer negative effects, including lower death rates, compared to older versions. The device also performed well across different heart shapes, achieving a 98% success rate in a large group of patients. In this trial, participants will be randomized to receive either the WATCHMAN FLX device or a non-vitamin K oral anticoagulant (NOAC). These findings suggest that the WATCHMAN FLX could serve as a viable alternative to traditional blood thinners for individuals with this condition. ^{1 5 6 7 8}

Who Is on the 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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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 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 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-implanter/clinical-evidence.html

Clinical Evidence - Studies and Trials - WATCHMAN FLX The Meta-analysis, the largest comparison of peri-procedural success and short-term outcomes between the WATCHMAN FLX Device and the Amplatzer Amulet device, ...

2. ahajournals.org ahajournals.org/doi/10.1161/JAHA.122.026295

Two‐Year Outcomes With a Next‐Generation Left Atrial ... In the PINNACLE FLX trial, the next‐generation WATCHMAN FLX device demonstrated 100% effective closure of the LAA and low rates of safety events ...

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

Efficacy and safety of the new generation Watchman FLX ... Conclusion: Compared to the W 2.5, the W-FLX was associated with a higher procedural success rate and significantly reduced adverse outcomes including mortality ...

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

SURPASS One-Year Results - Study Design The SURPASS data reinforces the procedural success of the WATCHMAN FLX Device with 98% of patients implanted (N=97,185)1 across nearly all anatomies in a real- ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0735109725060759/pdf

3-Year Clinical Outcomes Comparing the Amulet vs ... At 3 years after LAAC, there was no significant difference in the ischemic risk between the Amulet and the Watchman FLX groups.

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

Clinical Evidence These data continue to support the best-in-class safety of the WATCHMAN FLX Device with a 0.49% major procedural adverse event rate within 7 days or hospital ...

7. 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 ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11317688/

Safety and feasibility of atrial fibrillation ablation after left atrial ... In addition, 2‐year follow‐up outcome data demonstrated that the WATCHMAN LAAC device is an effective and safe alternative nonpharmacological therapy for stroke ...