Phase 4
Completed N=562
AtriClip® Left Atrial Appendage Exclusion Concomitant to Structural Heart Procedures (ATLAS)
Post-Operative Atrial Fibrillation
Source: ClinicalTrials.gov NCT02701062 ↗
Enrolled (actual)
562
Serious AEs
0.3%
Results posted
Nov 2021
Primary outcomePrimary: Number of Perioperative Complications Associated With AtriClip Placement — 0 perioperative complications reported
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 |
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. Informational only — not medical advice.