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

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

Summary

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").

Description

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

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

Eligibility

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)
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