Atrial Fibrillation, Bleeding, Stroke
Conditions
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.
Interventions
DEVICELeft atrial appendage occlusion (LAAO)
Implantation of an Amplatzer Amulet left atrial appendage occluder
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Presence of other conditions that, in the investigator's opinion, could limit the subject's ability to participate in follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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: Ischemic stroke or systemic embolism | Through 24 months | Composite of ischemic stroke or systemic embolism through 24 months |
Countries
United States
Outcome results
None listed