WATCHMAN FLX Versus NOAC for Embolic ProtectION in in the Management of Patients with Non-Valvular Atrial Fibrillation (CHAMPION-AF)

  • sponsor
    Boston Scientific Corporation
Updated on 18 October 2021
vitamin k antagonist
vitamin k
vascular disease
left atrial appendage closure


This study is a prospective, randomized, multi-center, global investigation to determine if left atrial appendage closure with the WATCHMAN FLX device is a reasonable alternative to Non-Vitamin K Antagonist Oral Anticoagulants (NOACs), in patients with non-valvular atrial fibrillation.

Subjects will be randomized to either the WATCHMAN FLX Left Atrial Appendage Closure Device ("Device Group") or a commercially available non-vitamin K oral anticoagulant ("Control Group").


  • Condition: Atrial Fibrillation, Stroke, Bleeding
  • Device: WATCHMAN FLX LAAC Device
  • Drug: Non-Vitamin K Oral Anticoagulant
  • Clinical Trial Identifier: NCT04394546
  • Sponsor: Boston Scientific Corporation

Condition Atrial Fibrillation, Heart Diseases, Arrhythmias, Cardiac, Atrial Fibrillation, Atrial Fibrillation (Pediatric)
Clinical Study IdentifierTX276511
SponsorBoston Scientific Corporation
Last Modified on18 October 2021


Yes No Not Sure

Inclusion Criteria

Male or female, ≥ 18 years of age
The subject has documented non-valvular atrial fibrillation (i.e., atrial fibrillation in the absence of moderate or greater mitral stenosis or a mechanical heart valve)
The subject has a calculated CHA2DS2-VASc score of 2 or greater for men and 3 or greater for women

Exclusion Criteria

The subject requires long-term anticoagulation therapy for reasons other than AF-related stroke risk reduction
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
The subject had a prior stroke) or transient ischemic attack 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, has an active bleed
The subject has a reversible cause of AF or transient AF
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
The subject has a history of atrial septal repair or has an ASD/PFO device
The subject has a known contraindication to TEE
The subject has a cardiac tumor, signs/symptoms of acute or chronic pericarditis and has an active infection
The subject has New York Heart Association Class IV Congestive Heart Failure at the time of enrollment
Transthoracic Echo Exclusion Criteria
1. The subject has LVEF < 30%
2. The subject has an existing pericardial effusion with a circumferential echo-free space > 5mm
3. The subject has a high-risk patent foramen ovale (PFO) with an atrial septal aneurysm excursion > 15mm or length > 15mm
4. The subject has significant mitral valve stenosis (i.e., MV area <1.5 cm2)
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact



Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note