Post-Operative Atrial Fibrillation Clinical Trial
Official title:
AtriClip® Left Atrial Appendage Exclusion Concomitant to Structural Heart Procedures (ATLAS)
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.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05223725 -
Gene Therapy for Post-Operative Atrial Fibrillation
|
Phase 1 | |
| Recruiting |
NCT06124937 -
Empagliflozin to Prevent Post-Operative Atrial Fibrillation
|
Phase 3 | |
| Completed |
NCT03943927 -
Preemptive Pharmacogenetic-guided Metoprolol Management for PostoperativeAtrial Fibrillation in Cardiac Surgery
|
N/A | |
| Completed |
NCT03779841 -
Botulinum Toxin Type A (AGN-151607) for the Prevention of Post-operative Atrial Fibrillation in Adult Participants Undergoing Open-chest Cardiac Surgery (NOVA)
|
Phase 2 | |
| Recruiting |
NCT04993456 -
Calcitonin Level and New-onset of Post-Operative Atrial Fibrillation
|
||
| Completed |
NCT03525860 -
Acupuncture Treatment for Patients Who Develop Arrhythmias in the Post-Operative Cardio-Thoracic Setting
|
N/A | |
| Recruiting |
NCT02029534 -
Intensive Statin Therapy Effect on Post-Operative Atrial Fibrillation (POAF)
|
Phase 4 |