MedTrace Logo

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

NCT02701062 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 562

Last updated 2021-11-24

Study results available
· View outcomes & findings →

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.

Conditions

  • Post-Operative Atrial Fibrillation

Interventions

DEVICE

AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems

DRUG

Anticoagulation Therapy

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

Sponsors & Collaborators

  • AtriCure, Inc.

    lead INDUSTRY

Principal Investigators

  • Sydney Gaynor, MD · AtriCure, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2019-04-26
Completion
2019-06-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02701062 on ClinicalTrials.gov