AMULET

Clinical Trial Title AMPLATZER™ Amulet™ LAA Occluder Trial (Amulet IDE)
Trial Status Open to Enrollment
Start Date 12/26/2016
Location legacy-emanuel-medical-center
Trial Type Heart Disease/Cardiology
Specific Condition Nonvalvular atrial fibrillation
Description The Amulet™ device will be evaluated for safety and efficacy by demonstrating its performance is non-inferior to the commercially available WATCHMAN® left atrial appendage closure device in patients with non-valvular atrial fibrillation. Patients who are eligible for the trial will be randomized to receive either the Amulet device or the WATCHMAN device and will be followed for 5 years after device implant.
Eligibility Criteria

Inclusion Criteria:

  1. 18 years of age or older
  2. Documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation (AF) and the patient has not been diagnosed with rheumatic mitral valvular heart disease
  3. At high risk of stroke or systemic embolism defined as CHADS2 score > 2 or a CHA2DS2-VASc score of > 3
  4. Has an appropriate rationale to seek an alternative to warfarin or other anticoagulation medication
  5. Deemed by investigator to be suitable for short term warfarin therapy but deemed unable to take long term oral anticoagulation following the conclusion of shared decision making (see inclusion criteria #6)
  6. Deemed suitable for LAA closure by a multidisciplinary team of medical professionals (including an independent non-interventional physician) involved in the formal and shared decision- making process, and by use of an evidence-based decision tool on oral anticoagulation (final determination must be documented in the subject's medical record)
  7. Able to comply with the required medication regimen post-device implant
  8. Able to understand and willing to provide written informed consent to participate in the trial
  9. Able to and willing to return for required follow-up visits and examinations
IRB Number 10687
Notes https://clinicaltrials.gov/ct2/show/NCT02879448
Principal Investigator Amish Desai, MD
Contact Name Karla Kummer
Contact Phone 503-692-8419
Contact Fax 503-692-7669
Contact E-Mail kkummer@lhs.org