NCT02701062

AtriClip® Left Atrial Appendage Exclusion Concomitant to Structural Heart Procedures (ATLAS)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 562 (actual)
• Sponsor: AtriCure, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients without a documented history of Atrial Fibrillation (AF) and will undergo a valve or Coronary Artery Bypass Graft (CABG) procedure with direct visual access to the Left Atrial Appendage (LAA) will be eligible to participate. Patients enrolled will be randomized 2:1 (2 with AtriClip to 1 without AtriClip. Subjects who develop Post-operative Atrial Fibrillation (POAF) and receive the AtriClip will be followed for 365 days post index procedure.

Detailed description

Patients without a documented history of AF but who present with a CHA2DS2- VASc (congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, stroke or transient ischemic attack (TIA), vascular disease, age 65 to 74 years, sex category) of =\> 2 and HASBLED (Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile INR, Elderly, Drugs/Alcohol Concomitantly) of =\> 2 and will undergo a valve or CABG (structural heart) procedure with direct visual access to the LAA will be eligible to participate based upon the inclusion and exclusion criteria defined in this protocol. Up to 2000 patients will enroll at up to 40 sites and will be randomized 2:1 (2 with AtriClip to 1 without AtriClip. Subjects who not develop Post-operative Atrial Fibrillation (POAF) will be followed for 30 days for safety. Subjects who develop POAF and receive the AtriClip will be followed for 365 days post index procedure.

Conditions

• Post-Operative Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems
DRUG	Anticoagulation Therapy	Anticoagulation Therapy- Standard of Care at the discretion of the Investigator.

Timeline

• Start date: 2016-02-01
• Primary completion: 2019-04-26
• Completion: 2019-06-01
• First posted: 2016-03-08
• Last updated: 2021-11-24
• Results posted: 2021-11-24

Locations

22 sites across 1 country: United States

Regulatory

• FDA-regulated device study