Phase 4
N=562
AtriClip® Left Atrial Appendage Exclusion Concomitant to Structural Heart Procedures (ATLAS)
Post-Operative Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT02701062 ↗Enrolled (actual)
562
Serious AEs
0.3%
Results posted
Nov 2021
Primary outcome: Primary: Number of Perioperative Complications Associated With AtriClip Placement — 0 perioperative complications reported
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems (Device); Anticoagulation Therapy (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AtriCure, Inc.
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Perioperative Complications Associated With AtriClip Placement |
— | — |
| SECONDARY Number of Subjects With Intraoperative Successful Exclusion of LAA. |
82.2; 95.4; 98.9 | — |
| SECONDARY Composite Event Rates Between Subjects Diagnosed With Post-operative Atrial Fibrillation (POAF) (Through 365 Days) |
19.6; 8.2; 16.0; 6.5; 9.9 | 0.2593 |
| SECONDARY Composite Event Rates Between Subjects Not Diagnosed With POAF (Through 30 Days) |
5.0; 5.1; 0.0; 8.0; 7.8 | 1.000 |
| SECONDARY Composite Event Rates for ALL Subjects Regardless of POAF Through 365 Days |
15.8; 6.7; 8.5; 14.8; 7.5; 8.6 | 0.1238 |
| SECONDARY Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Mean Values) |
9.1; 8.1; 8.4; 7.3; 7.7; 6.4 | 0.6603 |
| SECONDARY Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Median Values) |
7.0; 7.0; 9.0; 6.0; 6.0; 5.0 | 0.6603 |
| SECONDARY Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Event Rates) |
3.9; 2.7; 3.7; 1.3; 9.2; 3.3 | 0.5442 |
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.
Eligibility Criteria
Inclusion Criteria
Patients satisfying the following criteria will be considered the screening population and will be eligible for participation:
- Age > 18 years male or female.
- Scheduled for any non-mechanical valve and/or CABG (structural heart) procedure where direct access to the LAA is expected.
- No documented preoperative AF.
- CHA2DS2-VASc score of => 2.
- HASBLED score of => 2.
- Acceptable surgical candidate, including use of general anesthesia.
- Willing and able to provide written informed consent.
Exclusion Criteria
Patients satisfying the following criteria will not be eligible for participation:
- Redo cardiac surgery.
- Mechanical heart valve or other anticipated or current requirement for anticoagulation therapy during the post-operative (30 day) period.
- Hypercoagulability conditions that may confound the study.
- Ejection Fraction 6 cm.
- Severe Diastolic Dysfunction.
- Requires anticoagulation therapy.
- Patient had a stroke/cerebrovascular accident (CVA) within previous 30 days prior to signing informed consent.
Intra-Operative Exclusion Criteria
- Presence of thrombus in the left atrium or LAA.
- LAA tissue is deemed friable or has significant adhesions (as evaluated by the surgeon) near or on the LAA making AtriClip placement overly risky.
- Left atrial appendage is outside the range of manufacturer's recommendations - width 50mm.
- Direct visualization access is not available for AtriClip placement.
Data sourced from ClinicalTrials.gov (NCT02701062). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.