NCT06521463

SIMPLAAFY Clinical Trial

WATCHMAN FLX™ Pro Left Atrial Appendage Closure Device With Alternative Post-Implant Monotherapy

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,857 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a prospective, randomized, open-label, triple-arm, multi-center trial. Subjects will be randomized 1:1:1 to one of the three therapy arms and remain on treatment through the end of study (12 months): 1. Aspirin only 2. Reduced dose non-vitamin K antagonist (VKA) oral anticoagulant (NOAC) 3. DAPT

Conditions

• Atrial Fibrillation
• Stroke
• Bleeding

Interventions

Type	Name	Description
DEVICE	WATCHMAN FLX Pro LAAC Device	WATCHMAN FLX Pro LAAC Device Implantation

Timeline

• Start date: 2024-10-01
• Primary completion: 2026-07-01
• Completion: 2027-01-01
• First posted: 2024-07-26
• Last updated: 2026-04-14

Locations

87 sites across 1 country: United States

Regulatory

• FDA-regulated device study