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NCT06521463 · ClinicalTrials.gov registry record · NA
SIMPLAAFY Clinical Trial
A NA study of Stroke and Atrial Fibrillation, sponsored by Boston Scientific Corporation.
- Active
- Registry status
- NA
- Development phase
- 1,857
- Enrollment target
- 20
- Study locations
NCT06521463: Active NA study of Stroke and Atrial Fibrillation, sponsored by Boston Scientific Corporation.
NCT06521463 is a NA study of Stroke and Atrial Fibrillation that is active but no longer recruiting, run by Boston Scientific Corporation. The registered enrollment target is 1,857 participants, below the 12,012-participant average among 454 other Stroke trials with a reported enrollment target (85% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06521463, a NA study of Stroke and Atrial Fibrillation, is active but no longer recruiting, sponsored by Boston Scientific Corporation.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 1,857 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Non Inferiority
Conditions Studied
Interventions
- DEVICE WATCHMAN FLX Pro LAAC Device
Study Locations (20)
California
- Mills Peninsula Health Services - Burlingame
- John Muir Medical Center - Concord
- Scripps Memorial Hospital - La Jolla
- Loma Linda University Medical Center - Loma Linda
- St. John's Health Center - Los Angeles
- Santa Barbara Cottage Hospital - Santa Barbara
- Los Robles Hospital & Medical Center - Thousand Oaks
- Cardiology Associates Medical Group - Ventura
Arizona
- Phoenix Cardiovascular Research Group - Phoenix
- HonorHealth Heart Group - Shea - Scottsdale
- Tucson Medical Center Healthcare - Tucson
Alabama
- University of Alabama Birmingham - Birmingham
- Grandview Medical Center - Birmingham
Colorado
- Colorado Heart and Vascular PC - Lakewood
- Medical Center of the Rockies - Loveland
Florida
- Baptist Medical Center - Jacksonville
- HCA Florida Mercy Hospital - Miami
Arkansas
- Arrhythmia Research Group - Jonesboro
Connecticut
- Hartford Hospital - Hartford
District of Columbia
- Washington Hospital - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,857 participants |
| Start Date | 2024-10-01 |
| Est. Completion | 2027-01 |
| Phase | NA |
What the registry record for NCT06521463 still lists
NCT06521463 is an interventional study that assigns participants to a tested intervention. Its 1,857 participants enrollment target places it among the larger protocols in the corpus, below the 12,012-participant average among 454 other Stroke trials with a reported enrollment target (85% lower).
The record links to 3 conditions, with Stroke appearing as the primary indexed condition, and to 1 intervention - of which WATCHMAN FLX Pro LAAC Device is the first listed.
NCT06521463 names 20 study sites across 8 states, led by California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT06521463 about?
NCT06521463 is a clinical study titled "SIMPLAAFY Clinical 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.
What is the current status of trial NCT06521463?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 1,857 participants. The study started on 2024-10-01. Estimated completion is 2027-01.
What conditions does trial NCT06521463 study?
This clinical trial studies the following conditions: Stroke, Atrial Fibrillation, Bleeding.
What interventions are being tested in trial NCT06521463?
The interventions under investigation include: WATCHMAN FLX Pro LAAC Device (DEVICE).
Who is sponsoring clinical trial NCT06521463?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06521463 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stroke
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06521463's enrollment target sits among peer trials
1,857 28th of 454 higher than 427 of 454 other Stroke trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stroke trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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