drugset / Trial / NCT02701062

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

NCT02701062

Phase 4 Completed 562 enrolled AtriCure, Inc.
RandomizedParallel-groupOpen-labelOther

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.

Timeline

Start
2016-02
Primary completion
2019-04-26
Completion
2019-06-01

Drugs

EvaluationDrugModalityDoseRoute
Background Apixaban Small molecule
Background Dabigatran Unknown
Background Rivaroxaban Other / unclassified
Background Warfarin Small molecule

Indications