Active — Not RecruitingNot Applicable

SIMPLAAFY Clinical Trial

United States1,857 participantsStarted 2024-10-01

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subject is of legal age to participate in the study per the laws of their respective geography. * Subject is an acceptable candidate for a WATCHMAN FLX Pro device per the approved Instructions for Use. * Subject is deemed to be suitable for all protocol defined drug regimens in the control and both test arms. * The subject or legal representative is able to understand and willing to provide written informed consent to participate in the trial. * The subject is able and willing to return for required follow-up visits and examinations. Exclusion Criteria: * Subject's device implant procedure was aborted (i.e., failed implant). * Subject has a device margin residual leak \> 0mm at time of implant. * Occurrence of complications (major bleeding, systemic embolism, stroke, pericardial effusion requiring intervention) during the implant procedure, post-procedure, or prior to randomization. * Subject has a contraindication to one of the three protocol defined drug regimens. * Subject requires long-term anticoagulation therapy for reason other than AF-related stroke risk reduction or requires chronic P2Y12 inhibitor therapy. * Subject has known history of severe liver disease including cirrhosis with a Child-Pugh classification C or D. * Subject with known hypercoagulability disorder, mechanical heart valve, rheumatic heart disease, or recurrent deep vein thrombosis. * Subject has intracardiac thrombus, LAA sludge, or dense spontaneous echo contrast (SEC) obse…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 6 months after randomization

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.

Timeframe: 6 months after randomization

Trial details

NCT IDNCT06521463

SponsorBoston Scientific Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-07

View on ClinicalTrials.gov More Atrial Fibrillation trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Timeframe: 6 months after randomization