Amulet™ ADVANCE LAA

Abbott

Status: Active, not recruiting

Conditions: Atrial Fibrillation; Stroke; Bleeding

Treatments: Device: Left atrial appendage occlusion (LAAO)

Study type: Observational

Funder types: Industry

Identifiers

NCT05997446

ABT-CIP-10467

CRD_1056 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 610 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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