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NCT02701062 · ClinicalTrials.gov registry record · Phase 4
AtriClip® Left Atrial Appendage Exclusion Concomitant to Structural Heart Procedures (ATLAS)
A Phase 4 study of Post Operative Atrial Fibrillation, sponsored by AtriCure.
- Completed
- Registry status
- Phase 4
- Development phase
- 562
- Enrollment target
- 20
- Study locations
NCT02701062: Completed Phase 4 study of Post Operative Atrial Fibrillation, sponsored by AtriCure.
NCT02701062 is a Phase 4 study of Post Operative Atrial Fibrillation that has completed, run by AtriCure. The registered enrollment target is 562 participants, above the 473-participant average among 5 other Post Operative Atrial Fibrillation trials with a reported enrollment target (19% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02701062, a Phase 4 study of Post Operative Atrial Fibrillation, has completed, sponsored by AtriCure.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 562 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Defined as: stroke, major bleeding that requires re-operation and/or transfusion of \> 2 U packed red blood cells (PRBC), myocardial infarction (MI), or death.
Conditions Studied
Interventions
- DEVICE AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems
- DRUG Anticoagulation Therapy
Study Locations (20)
New York
- NYU Langone Medical Center - New York
- Mount Sinai -St. Luke's - New York
- Icahn School of Medicine at Mount Sinai - New York
California
- Sharp Memorial Hospital - San Diego
- Stanford University - Stanford
Indiana
- St Francis Heart Hospital - Indianapolis
- St. Vincent Heart Center, Inc. - Indianapolis
Ohio
- The Christ Hospital -Linder Research Center - Cincinnati
- Tri-Health - Cincinnati
Tennessee
- Wellmont CVA Heart Institute - Kingsport
- Cardiovascular Surgery Clinic - Memphis
Florida
- Orlando Health Heart Institute - Orlando
Georgia
- Emory St Joseph Hospital - Atlanta
Kansas
- University of Kansas Hospital - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 562 participants |
| Start Date | 2016-02 |
| Est. Completion | 2019-06-01 |
| Phase | Phase 4 |
What the finished NCT02701062 record still lists
NCT02701062 is an interventional study that assigns participants to a tested intervention. The registered 562 participants enrollment target is mid-sized for trials with a published cap, above the 473-participant average among 5 other Post Operative Atrial Fibrillation trials with a reported enrollment target (19% higher).
The record links to 1 condition, with Post Operative Atrial Fibrillation appearing as the primary indexed condition, and to 2 interventions - of which AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems is the first listed.
NCT02701062 names 20 study sites across 14 states, led by New York, California, Indiana.
Frequently Asked Questions
What is clinical trial NCT02701062 about?
NCT02701062 is a clinical study titled "AtriClip® Left Atrial Appendage Exclusion Concomitant to Structural Heart Procedures (ATLAS)". 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 wit...
What is the current status of trial NCT02701062?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 562 participants. The study started on 2016-02. Estimated completion is 2019-06-01.
What conditions does trial NCT02701062 study?
This clinical trial studies the following conditions: Post Operative Atrial Fibrillation.
What interventions are being tested in trial NCT02701062?
The interventions under investigation include: AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems (DEVICE), Anticoagulation Therapy (DRUG).
Who is sponsoring clinical trial NCT02701062?
This trial is sponsored by AtriCure, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02701062 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Indiana, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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