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8110 Gatehouse Road, Falls Church, VA 22042

Watchman FLX versus NOAC for Embolic Protection Management of Patients with Non-Valvular Atrial Fibrillation (CHAMPION-AF)

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General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NCT04394546, IDE # G200106

Background Information

A prospective multicenter randomized trial to evaluate the safety and efficacy of the WATCHMAN FLX LAAC device vs. direct acting oral anticoagulants for first-line therapy in the prevention of stroke in patients with nonvalvular atrial fibrillation.

Offered At

Inova Fairfax Hospital
3300 Gallows Rd.
Falls Church, VA 22042

Principal Investigator

Matthew Sherwood, MD

Eligibility Information

  • Subject is of legal age to participate in the study per the laws of their respective geography
  • Subject has documented non-valvular atrial fibrillation
  • The subject has a calculated CHA2DS-VAScscore of 2 or greater for men and 3 or greater for women
  • Subject is deemed suitable for the protocol defined pharmacologic regimens in both the test and control arms
  • The subject requires long-term anticoagulation therapy for reasons other than AF-related stroke risk reduction

Ineligibility Information

  • 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
  • The subject has an active bleed
  • The subject has a reversible cause of AF or transient AF