Amulet™ ADVANCE LAA

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05997446
• Collaborator: (none)
• Enrollment: 1,000
• Locations: 6
• Anticipated Duration (Months): 46.7
• Patients Per Site: 166.7
• Patients Per Site Per Month: 3.6

Study Details

Study Description

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. 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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation; Stroke; Bleeding	Device: Left atrial appendage occlusion (LAAO)

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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 1000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Real-World Study to Observe Outcomes of Patients Undergoing Closure With the Amplatzer™ Amulet™ Left Atrial Appendage Occluder
• Actual Study Start Date: Jul 12, 2023
• Anticipated Primary Completion Date: Jun 1, 2027
• Anticipated Study Completion Date: Jun 1, 2027

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

3. Composite endpoint: Ischemic stroke or systemic embolism [Through 24 months]

   Composite of ischemic stroke or systemic embolism through 24 months

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Arrhythmia Research	Phoenix	Arizona	United States	85016
2	Arrhythmia Research Group	Jonesboro	Arkansas	United States	72401
3	Arkansas Heart Hospital	Little Rock	Arkansas	United States	72211
4	Baptist Medical Center	Jacksonville	Florida	United States	32207
5	Kansas City Cardiac Arrhythmia Research Foundation	Overland Park	Kansas	United States	66211
6	Bryan Heart	Lincoln	Nebraska	United States	68506

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Principal Investigator: Dhanunjaya Lakkireddy, MD, Kansas City Cardiac Arrhythmia Research Foundation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT05997446
• Other Study ID Numbers: ABT-CIP-10467; CRD_1056
• First Posted: Aug 18, 2023
• Last Update Posted: Aug 18, 2023
• Last Verified: Aug 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

No Results Posted as of Aug 18, 2023