๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-06

SIMPLAAFY Clinical Trial (NCT06521463)

WATCHMAN FLXโ„ข Pro Left Atrial Appendage Closure Device With Alternative Post-Implant Monotherapy

๐Ÿ”ต Active, Not Recruiting Observational / Diagnostic โš™๏ธ Medical Device Protocol Sponsor: Boston Scientific Corporation

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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 join: Review the eligibility criteria below.

Location: University of Alabama Birmingham โ€” Birmingham, Alabama

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (86 Sites)

Showing the first 25 of 86 sites.

  • University of Alabama Birmingham โ€” Birmingham, Alabama
  • Grandview Medical Center โ€” Birmingham, Alabama
  • Phoenix Cardiovascular Research Group โ€” Phoenix, Arizona
  • HonorHealth Heart Group - Shea โ€” Scottsdale, Arizona
  • Tucson Medical Center Healthcare โ€” Tucson, Arizona
  • Arrhythmia Research Group โ€” Jonesboro, Arkansas
  • Mills Peninsula Health Services โ€” Burlingame, California
  • John Muir Medical Center โ€” Concord, California
  • Scripps Memorial Hospital โ€” La Jolla, California
  • Loma Linda University Medical Center โ€” Loma Linda, California
  • St. John's Health Center โ€” Los Angeles, California
  • Santa Barbara Cottage Hospital โ€” Santa Barbara, California
  • Los Robles Hospital & Medical Center โ€” Thousand Oaks, California
  • Cardiology Associates Medical Group โ€” Ventura, California
  • Colorado Heart and Vascular PC โ€” Lakewood, Colorado
  • Medical Center of the Rockies โ€” Loveland, Colorado
  • Hartford Hospital โ€” Hartford, Connecticut
  • Washington Hospital โ€” Washington D.C., District of Columbia
  • Baptist Medical Center โ€” Jacksonville, Florida
  • Naples Community Hospital โ€” Naples, Florida
  • Sarasota Memorial Hospital โ€” Sarasota, Florida
  • Emory University Hospital โ€” Atlanta, Georgia
  • Georgia Arrhythmia Consultants โ€” Macon, Georgia
  • Wellstar Kennestone Hospital โ€” Marietta, Georgia
  • Memorial Health University Medical Center โ€” Savannah, Georgia

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—