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COMPLETED Phase 4

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

NCT02701062 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 562 participants
Start Date 2016-02
Est. Completion 2019-06-01
Phase Phase 4

Sponsor

AtriCure

13 total trials

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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. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 13 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02701062 reports 20 study locations spanning 14 distinct geographic areas — top geographies include New York, California, Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02701062?

The interventions under investigation include: AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems (DEVICE), Anticoagulation Therapy (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02701062?

This trial is sponsored by AtriCure, which has 13 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial