🏛️ Verified NIH Record • Updated 2026-08-11

CHAMPION-AF Clinical Trial (NCT04394546)

WATCHMAN FLX Versus NOAC for Embolic ProtectION in in the Management of Patients With Non-Valvular Atrial Fibrillation

🔵 Active, Not Recruiting Observational / Diagnostic 💊 Investigational Drug / Biologic Sponsor: Boston Scientific Corporation

🩺 Plain-English Summary (8th-Grade Level)

The primary objective of this study is to determine if left atrial appendage closure (LAAC) with the WATCHMAN FLX device is a reasonable alternative to non-vitamin K oral anticoagulants in patients with non-valvular atrial fibrillation.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (27 items).

Location: Grandview Medical Center — Birmingham, Alabama

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Subjects who are currently enrolled in another investigational study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments
  • The subject requires long-term anticoagulation therapy for reasons other than AF-related stroke risk reduction, for example due to an underlying hypercoagulable state (i.e., even if the device is implanted, the subjects would not be eligible to discontinue OAC due to other medical conditions requiring chronic OAC therapy)
  • The subject is contraindicated or allergic to oral anticoagulation medication and/or aspirin
  • The subject is indicated for chronic P2Y12 platelet inhibitor therapy
  • The subject had or is planning to have any cardiac or non-cardiac intervention or surgical procedure within 30 days prior to or 60 days after implant (including, but not limited to: cardioversion, percutaneous coronary intervention (PCI), cardiac ablation, cataract surgery, etc.)
  • The subject had a prior stroke (of any cause, whether ischemic or hemorrhagic) or transient ischemic attack (TIA) within the 30 days prior to enrollment
  • The subject had a prior major bleeding event per ISTH definition within the 30 days prior to randomization. Lack of resolution of related clinical sequelae or planned and pending interventions to resolve bleeding/bleeding source, are a further exclusion regardless of timing of the bleeding event
  • The subject has an active bleed
  • The subject has a reversible cause of AF or transient AF
  • The subject is absent of a left atrial appendage (LAA) or the LAA is surgically ligated
  • The subject has had a myocardial infarction (MI) documented in the clinical record as either a non-ST elevation MI (NSTEMI) or as an ST-elevation MI (STEMI), with or without intervention, within 30 days prior to enrollment

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (141 Sites)

Showing the first 25 of 141 sites.

  • Grandview Medical Center — Birmingham, Alabama
  • University of Alabama at Birmingham — Birmingham, Alabama
  • Arizona Arrhythmia Research Center — Phoenix, Arizona
  • Phoenix Cardiovascular Research Group — Phoenix, Arizona
  • Scottsdale Healthcare - Shea — Scottsdale, Arizona
  • Tucson Medical Center Healthcare — Tucson, Arizona
  • Arrythmia Research Group — Jonesboro, Arkansas
  • Sharp Chula Vista Medical Center — Chula Vista, California
  • Marin General Hospital — Greenbrae, California
  • Scripps Memorial Hospital — La Jolla, California
  • Los Robles Hospital and Medical Center — Los Angeles, California
  • El Camino Hospital — Mountain View, California
  • Eisenhower Medical Center — Rancho Mirage, California
  • Mercy General Hospital — Sacramento, California
  • Santa Barbara Cottage Hospital — Santa Barbara, California
  • St. John's Health Center — Santa Monica, California
  • Colorado Springs Cardiologist, P.C. — Colorado Springs, Colorado
  • Yale University School of Medicine — New Haven, Connecticut
  • Christiana Hospital — Newark, Delaware
  • Washington Hospital Center — Washington D.C., District of Columbia
  • Manatee Memorial Hospital — Bradenton, Florida
  • Bay Area Cardiology Associates, P.A. — Brandon, Florida
  • Broward General Medical Center — Fort Lauderdale, Florida
  • St. Vincent's Medical Center — Jacksonville, Florida
  • Lakeland Regional Medical Center — Lakeland, Florida

💰 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 § 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.

More studies in Atrial Fibrillation

Explore by condition: All Atrial Fibrillation clinical trials

💡 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.
🏛️ View Official NIH Record ↗