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Watchman FLX versus NOAC for the Embolic Protection in the Management of Patients with non-Valvular Atrial Fibrillation (Champion-AF)

Study Type/Phase: Prospective, Randomized, Multi-center Global Investigation
Status: Recruiting

This research study addresses a common sustained heart rhythm disorder known as non-valvular atrial fibrillation (AF). Atrial fibrillation affects your heart’s ability to pump blood normally, causing blood to pool in an area of your heart called the left atrial appendage (LAA). Everyone has a LAA (which is like a pouch on the top of your heart) that developed before birth. In the LAA, AF can cause blood cells to stick together and form a clot. If a blood clot escapes from the LAA and travels to another part of the body, it can cut off the blood supply to the brain, causing a stroke. A clot can increase your chances of having a stroke or other related problems.

The current standard of care to prevent stroke in patients with AF is long-term oral anticoagulation (OAC) therapy (blood thinner medication) or, in appropriately selected patients, implant of a WATCHMAN FLXTM device. The purpose of this study is to determine if LAA closure with the WATCHMAN FLXTM Device is safe and effective as a reasonable alternative to long-term use of a category of anticoagulation drugs called non-vitamin K antagonist oral anticoagulation, also known as NOACs. The medications and the device used in this study are already approved for use in the U.S.

Subjects in this study will be randomized 1:1 to either the device group receiving the WATCHMAN FLX™ device, or the control group, treatment with anticoagulant drugs referred to as NOACs, non-vitamin K antagonist oral anticoagulation. All subjects will be followed for five years.

Speak with your doctor to determine whether you meet the following criteria for participation in this study.

Inclusion Criteria Exclusion Criteria
  • Documented non-valvular atrial fibrillation
  • Able and willing to return for required follow-up visits and examinations
  • Clinical evaluation demonstrates suitability for inclusion in the study.
  • Requires long-term anticoagulation therapy for reasons other than AF-related stroke risk reduction
  • Contraindicated or allergic to oral anticoagulation medication and/or aspirin Indicated for chronic P2Y12 platelet inhibitor therapy
  • 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

Principal Investigator

Rammohan, Chad MD

Sponsor

Boston Scientific Corporation

NCT Number

04394546

Contact

Janet Lamm, Sr. Clinical Research Coordinator
650-962-4566
Janet_Lamm@elcaminohealth.org

For more information about this clinical trial, including trial status, eligibility and full trial listing, visit www.clinicaltrials.gov.

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