NCT05997446

Amulet™ ADVANCE LAA

Study Contact:

The ADVANCE LAA Study Team - Role: CONTACT - Phone: (651) 756-5400 - Email: ADVANCE_LAA@abbott.com

Study Phase:

Recruitment Status:

RECRUITING

NCT ID:

NCT05997446

Principal Investigator:

Study Type:

OBSERVATIONAL

Official Title:

A Real-World Study to Observe Outcomes of Patients Undergoing Closure With the Amplatzer™ Amulet™ Left Atrial Appendage Occluder

Summary

This is a prospective, multicenter, observational study intended to characterize real-world outcomes on the commercially available Amulet device in the United States. The study will enroll approximately 1000 subjects at up to 50 US clinical sites. Subjects will be followed through 24 months in accordance with each site's standard care practices.

Eligibility

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

Disease(s) and\or Condition(s)

Atrial Fibrillation

Stroke

Bleeding

Primary Purpose

Intervention/Treatment

- Type: DEVICE
- Name: Left atrial appendage occlusion (LAAO)
- Description: Implantation of an Amplatzer Amulet left atrial appendage occluder
- Arm Group Labels:

Sponsor

Abbott Medical Devices