CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 562 enrolled
Drug / intervention
Anticoagulation Therapy +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02701062
NCT02701062Phase 4Completed
CompareCT.gov

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

AtriCure, Inc.·interventional·Posted Mar 8, 2016·Updated Nov 24, 2021

In Brief

A Phase 4 clinical trial evaluating AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems and Anticoagulation Therapy for Post-Operative Atrial Fibrillation. Completed, enrolled 562 participants across 22 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPost-Operative Atrial Fibrillation
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 8, 2016
Enrollment StartFeb 1, 2016
Primary CompletionApr 26, 2019
Study CompletionJun 1, 2019
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 10.3 years ago

Interventions

AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systemsdevice

Anticoagulation Therapydrug

Anticoagulation Therapy- Standard of Care at the discretion of the Investigator.