AMPLATZER AMULET Left Atrial Appendage Occluder Randomized Controlled Trial
NCT02879448
Heart & Vascular - Structural Heart Trials,
Heart & Vascular
Sameer Gafoor, MD
St. Jude Medical
Basic eligibility requirements include:
- Documented paroxysmal, persistent or permanent non-valvular atrial fibrillation
- No rheumatic mitral valvular heart disease
- At high risk of stroke or systemic embolism defined as CHADS2 score >2 or CHADS2-VASC score of >3
- Has an appropriate rationale to seek an alternative to warfarin or other anticoagulation medication
- Deemed by investigator to be suitable for short term warfarin but unable to take long term oral anticoagulation
- Deemed suitable for LAA closure by multidisciplinary team
Basic exclusions include:
- Requires long-term anticoagulation therapy for a condition other than AF
- Contraindicated for or allergic to aspirin, clopidogrel, or warfarin use
- Indicated for chronic P2Y12 platelet therapy inhibitor
- Has undergone ASD or PFO repair or has ASD or PFO closure device
- Implanted with mechanical valve prosthesis
- Has contraindications to percutaneous catheterization procedure or cannot accomodate TEE probe
- Stroke or TIA within 90 days prior to randomization or intervention or surgery planned within 60 days after implant procedure
- MI within 90 days of randomization
- NYHA Class IV Congestive Heart Failure
- Symptomatic carotid artery disease
- Resting Heart rate > 110bpm
Jeremy Gillis, Research Coordinator II
206-215-6573
206-215-1500