WATCHMAN FLX Pro Device for Atrial Fibrillation

(SIMPLAAFY Trial)

Recruiting at 50 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

Trial Summary

What is the purpose of this trial?

The primary objective is to demonstrate the safety and effectiveness of two monotherapy regimens versus dual antiplatelet (DAPT) therapy following post-implant with the WATCHMAN FLX Pro device in a commercial clinical setting.

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.

Research Team

Saibal Kar, MD

Principal Investigator

Los Robles Health System

Walid Saliba, MD

Principal Investigator

The Cleveland Clinic

Vivek Reddy, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

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

Key

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.

Timeline

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

Treatment Details

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.

Participant Groups

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