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AMULET

Trial

Clinical Trial Title

AMULET

Trial Status

Open to Enrollment

Start Date

December 26, 2016

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

Principal Investigator Name

Amish Desai, MD

Contact Name

Karla Kummer

Phone

503-692-8419

Contact Fax

503-692-7669

Contact E-Mail

kkummer@lhs.org

Last Updated: Thursday, September 21, 2017 07:43:31 AM