WATCHMAN FLX Pro Device for Atrial Fibrillation (SIMPLAAFY Trial)

N/A

Recruiting

Led By Saibal Kar, MD

Research Sponsored by Boston Scientific Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months after randomization

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to compare the safety and effectiveness of two different treatments with taking two medications together after receiving the WATCHMAN FLX Pro device in a real-world clinical setting. Summary: "This trial

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects may include complications from the device implantation like bleeding or heart-related issues, reactions to medications used during treatment, or other unforeseen risks associated with medical devices.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months after randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months after randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months after randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Aspirin Arm Primary Endpoint: Composite rate of all death, all stroke, systemic embolism, and ISTH major bleeding at 6-months after randomization in the Aspirin arm tested for non-inferiority compared to the DAPT arm.

Reduced dose NOAC Arm Primary Endpoint: Composite rate of all death, all stroke, systemic embolism, and ISTH major bleeding at 6-months after randomization in the reduced dose NOAC arm tested for non-inferiority compared to the DAPT arm

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Reduced dose non-vitamin K antagonist (VKA) oral anticoagulant (NOAC)Experimental Treatment1 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: AspirinExperimental Treatment1 Intervention

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

Group III: DAPTActive Control1 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

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