Amulet™ ADVANCE LAA
- Conditions
- BleedingAtrial FibrillationStroke
- Registration Number
- NCT05997446
- Lead Sponsor
- Abbott Medical Devices
- Brief Summary
This is a prospective, multicenter, observational study intended to characterize real-world outcomes on the commercially available Amulet device in the United States. Over 600 subjects have been enrolled at 16 US clinical sites. Subjects will be followed through 24 months in accordance with each site's standard care practices.
- Detailed Description
The ADVANCE LAA study is intended to characterize real-world outcomes of patients receiving the commercially available Amulet device in the United States. The Amulet device is intended to reduce the risk of thrombus embolization from the left atrial appendage (LAA) in patients who have nonvalvular atrial fibrillation (NVAF) and who are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores, are suitable for short-term anticoagulation therapy, and have appropriate rationale to seek a non-pharmacologic alternative to oral anticoagulation, taking into consideration the safety and effectiveness of the device.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 610
- Intended for LAAO with the Amulet device
- At least 18 years of age
- Willing and capable of providing informed consent and participating in all testing associated with this clinical study
- Presence of other conditions that, in the investigator's opinion, could limit the subject's ability to participate in follow-up
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Device closure, defined as residual jet around the device ≤ 3mm Assessed at first trans-esophageal echocardiogram (TEE) occurring between 30-240 days post-implant. Device closure (defined as residual jet around the device ≤ 3mm) at the first follow-up visit documented by trans-esophageal echocardiography (TEE), as assessed by an independent core laboratory
Composite endpoint: Death or complications Within 7 days of implant or hospital discharge, whichever is later Composite of all-cause death, ischemic stroke, systemic embolism, or device/procedure related complications requiring an invasive surgical or percutaneous intervention within 7 days of implant or hospital discharge, whichever is later
Composite endpoint: Ischemic stroke or systemic embolism Through 24 months Composite of ischemic stroke or systemic embolism through 24 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (16)
New York University Hospital
🇺🇸New York, New York, United States
Baptist Medical Center
🇺🇸Jacksonville, Florida, United States
Trident Medical Center
🇺🇸Charleston, South Carolina, United States
Pinnacle Health System
🇺🇸Mechanicsburg, Pennsylvania, United States
Heart Rhythm Associates
🇺🇸Shenandoah, Texas, United States
PERC - O'Fallon
🇺🇸O'Fallon, Illinois, United States
Bryan Heart
🇺🇸Lincoln, Nebraska, United States
Usman R. Siddiqui, MD
🇺🇸Winter Park, Florida, United States
Cardiovascular Research Institute of Kansas
🇺🇸Wichita, Kansas, United States
Kansas City Cardiac Arrhythmia Research Foundation
🇺🇸Overland Park, Kansas, United States
Arizona Arrhythmia Research
🇺🇸Phoenix, Arizona, United States
Vanderbilt Heart & Vascular Institute
🇺🇸Nashville, Tennessee, United States
Baylor All Saints Medical Center at Fort Worth
🇺🇸Fort Worth, Texas, United States
Arkansas Heart Hospital
🇺🇸Little Rock, Arkansas, United States
CHI Health Creighton University Medical Center-Bergan Mercy
🇺🇸Omaha, Nebraska, United States
Providence Hospital
🇺🇸Southfield, Michigan, United States