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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 is a Phase 4 study of Post Operative Atrial Fibrillation that has completed, run by AtriCure. The registered enrollment target is 562 participants. The trial reports 20 study locations across 14 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02701062
The ClinicalTrials.gov registry entry for NCT02701062 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 562 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AtriCure, which has 23 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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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