WATCHMAN FLX Pro Device for Atrial Fibrillation

(SIMPLAAFY Trial)

Recruiting at 93 trial locations

Overseen By Andrea Natale, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston Scientific Corporation

Must not be taking: Anticoagulants, P2Y12 inhibitors

Disqualifiers: Severe liver disease, Hypercoagulability, Stroke, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

1857 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of different medication regimens for individuals with atrial fibrillation who have had the WATCHMAN FLX Pro device (a left atrial appendage closure device) implanted. It compares three approaches: a combination of aspirin and clopidogrel, a reduced dose of a blood thinner (NOAC), and aspirin alone. The goal is to determine which treatment plan best prevents complications after device implantation. This trial suits those with atrial fibrillation considering the WATCHMAN FLX Pro device implantation. As an unphased trial, it provides an opportunity to explore various treatment options and contribute to a broader understanding of post-implant care.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications. However, you cannot participate if you require long-term anticoagulation therapy for reasons other than reducing stroke risk from atrial fibrillation or if you need chronic P2Y12 inhibitor therapy.

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

Research shows that the WATCHMAN FLX Pro device is safe for patients with atrial fibrillation. Studies have found that serious problems are rare, with only 0.45% of patients experiencing major issues within the first week after the procedure. Another study reported a 0.37% rate of major issues within a week or before leaving the hospital. These findings suggest that most patients tolerate the device well.

For those considering joining a trial, it's important to know that this device is already approved to help reduce stroke risk in people with certain heart conditions. This approval indicates it has been tested and found safe for use in people, at least for its current purpose. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the WATCHMAN FLX Pro Device for atrial fibrillation because it offers a unique alternative to traditional blood thinners. Unlike standard drugs like warfarin or other anticoagulants, this device is implanted in the heart to physically block clots from forming, potentially reducing bleeding risks associated with long-term medication use. It provides a targeted solution that could improve patient safety and life quality by minimizing the side effects typically seen with oral anticoagulants. This innovative approach could be a game-changer for those who cannot tolerate conventional therapies.

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

Research shows that the WATCHMAN FLX Pro device is a good option for people with atrial fibrillation to lower their risk of stroke. Studies have found a very low chance of major problems soon after the procedure. Specifically, one study found that only 0.45% of patients experienced significant issues within a week. The device has been successfully implanted in all procedures, and some patients can even go home the same day. This trial will compare the WATCHMAN FLX Pro device with different medication regimens. The WATCHMAN FLX Pro is as effective as blood thinners in preventing strokes but offers greater safety, allowing many patients to stop using these medications. This makes it a promising choice for those needing an alternative to long-term blood thinner use. ^{2 4 5 6 7}

Who Is on the Research Team?

Walid Saliba, MD

Principal Investigator

The Cleveland Clinic

Saibal Kar, MD

Principal Investigator

Los Robles Health System

Vivek Reddy, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

The SIMPLAAFY trial is for adults who can have the WATCHMAN FLX Pro device implanted according to its usage instructions. Participants must be able to take all study drugs and come back for follow-ups. They need to understand and agree in writing to join the study.

Inclusion Criteria

I am a suitable candidate for the WATCHMAN FLX Pro device as per its usage guidelines.

I can understand and am willing to sign the consent form.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to one of three therapy arms: Aspirin only, Reduced dose NOAC, or DAPT, and remain on treatment for 12 months

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• WATCHMAN FLX Pro LAAC Device

Trial Overview This trial tests if using one drug alone is as safe and effective as taking two together after getting a WATCHMAN FLX Pro device, which helps prevent strokes in people with atrial fibrillation by closing off an area of the heart.

How Is the Trial Designed?

Group I: Reduced dose non-vitamin K antagonist (VKA) oral anticoagulant (NOAC) Experimental Treatment 1 Intervention

Reduced dose non-vitamin K antagonist (VKA) oral anticoagulant (NOAC) for the first 3 months daily, post implant, followed by aspirin only for the duration of the clinical trial

Group II: Aspirin Experimental Treatment 1 Intervention

Aspirin 81-100 mg, daily post implant for duration of the clinical trial

Group III: DAPT Active Control 1 Intervention

DAPT (aspirin 81-100 mg + clopidogrel 75 mg), for the first 6-months daily followed by aspirin only for the duration of the clinical trial

WATCHMAN FLX Pro LAAC Device is already approved in United States for the following indications:

Approved in United States as WATCHMAN FLX Pro for:

• Reduction of stroke risk in patients with non-valvular atrial fibrillation who need an alternative to oral anticoagulation therapy

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

Citations

1. 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.

2. 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 ...

3. 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 ...

4. 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% ...

5. acforum.org acforum.org/web/resource_files/1739291757-34025.pdf

WATCHMAN FLX™ Pro INDICATIONS FOR USE. The WATCHMAN FLX Pro Device is indicated to reduce the risk of thromboembolism from the left atrial appendage in patients with non-valvular ...

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

SURPASS real-world data These data continue to support the best-in-class safety profile of the WATCHMAN FLX Implant with a 0.45% major procedural adverse event rate within seven days ...