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:
- 18 years of age or older
- Documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation (AF) and the patient has not been diagnosed with rheumatic mitral valvular heart disease
- At high risk of stroke or systemic embolism defined as CHADS2 score > 2 or a CHA2DS2-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 therapy but deemed unable to take long term oral anticoagulation following the conclusion of shared decision making (see inclusion criteria #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)
- Able to comply with the required medication regimen post-device implant
- Able to understand and willing to provide written informed consent to participate in the trial
- 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 |