Pivotal Study Of A Dual Epicardial & Endocardial Procedure (DEEP) Approach

Last updated: November 26, 2024
Sponsor: AtriCure, Inc.
Overall Status: Completed

Phase

N/A

Condition

Arrhythmia

Chest Pain

Cardiac Disease

Treatment

AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System, Endocardial Ablation

Clinical Study ID

NCT02393885
CP2014-1
  • Ages 18-75
  • All Genders

Study Summary

The objective of this study is to establish the safety and effectiveness of a dual epicardial and endocardial ablation procedure for patients presenting with Persistent Atrial Fibrillation or Longstanding Persistent Atrial Fibrillation

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Symptomatic Persistent Atrial Fibrillation or Longstanding Persistent AtrialFibrillation refractory to a minimum of one Class I or Class III AADs.

Exclusion

Exclusion Criteria:

  1. AF >10 years.

  2. Refractory hypertension, defined as systolic (>150 mm Hg) or diastolic (> 90 mm Hg)blood pressure that remains uncontrolled despite sustained therapy

  3. History of pulmonary hypertension

  4. Pulmonary vein stenosis in one or more of the pulmonary veins

  5. EP catheter ablation procedure to treat atrial fibrillation within 3 months

  6. Undergone prior cardiothoracic surgery, previous thorax trauma which resulted in apneumothorax or hemothorax.

  7. Sleep apnea, home oxygen therapy, moderate to severe COPD, (FEV1/FVC < 70%predicted) or patient is considered intolerant to single lung ventilation.

  8. NYHA Class IV heart failure.

  9. Uncorrected, reversible cause(s) of atrial fibrillation, or is currently beingtreated for arrhythmias other than atrial fibrillation (AF) or atrial flutter.

  10. Documented history of previous catheter ablation with perforation, history ofpericarditis, pericardial effusion, or tamponade.

  11. Structural heart disease requiring surgical treatment (i.e. valve disease requiringrepair or replacement within 12 months following surgical ablation procedure).

  12. CAD requiring intervention (either surgical, i.e. CABG, or catheter).

  13. Ejection fraction < 30%

  14. Measured left atrial diameter > 5.5 cm

  15. Stroke/cerebrovascular accident (CVA) within previous six months, carotid arterystenosis greater than 80%.

  16. BMI is >40

  17. Thrombus in the left atrium or the left atrial appendage, determined byechocardiography (either at baseline TTE (or equivalent diagnostic test) orintraoperative TEE).

  18. Blood dyscrasia or clotting disorder (i.e. Idiopathic Thrombocytopenic Purpura [ITP]or Thrombotic Thrombocytopenic Purpura [TTP]).

  19. Contraindication to anticoagulation that in the opinion of the investigator posesundue risk to the patient from participating in the endocardial EP procedure.

  20. Documented thromboembolism within the previous six months prior to signing informedconsent.

  21. Has the following atrial myxoma, mural thrombus or mural tumor.

  22. A condition or congenital anomaly which prevents required surgical or catheteraccess.

  23. A co-morbid condition that, in the opinion of the investigator, poses undue risk ofgeneral anesthesia or port access cardiac surgery.

  24. Currently abusing drugs or alcohol.

  25. Currently or has participated in a clinical study in the last 3 months prior tosigning informed consent.

  26. A psychological disorder that could interfere with provision of informed consent,completion of tests, therapy, or follow-up.

  27. A condition that, in the opinion of the investigator, may jeopardize the patient'swell-being and/or the soundness of this clinical study.

  28. Pre-existing esophageal condition that required (or requires) endoscopic therapy orsurgical treatment.

Study Design

Total Participants: 90
Treatment Group(s): 1
Primary Treatment: AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System, Endocardial Ablation
Phase:
Study Start date:
February 01, 2015
Estimated Completion Date:
April 17, 2024

Study Description

The objective of this study is to establish the safety and effectiveness of a dual epicardial and endocardial ablation procedure for patients presenting with Persistent Atrial Fibrillation or Longstanding Persistent Atrial Fibrillation utilizing the AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System in an endoscopic or open ablation procedure, followed by an endocardial mapping and ablation procedure utilizing commercially available RF based, irrigated, power controlled, ablation catheters for endocardial lesions. The endocardial procedure will be staged to occur after 90 days post epicardial surgical procedure.

Connect with a study center

  • Universitair Ziekenhuis Brussel (UZ Brussels)

    Brussels,
    Belgium

    Site Not Available

  • Academic Medical Center (AMC)

    Amsterdam,
    Netherlands

    Site Not Available

  • Long Beach Memorial Medical Center

    Long Beach, California 90806
    United States

    Site Not Available

  • Cedars-Sinai Heart Institute

    Los Angeles, California 90048
    United States

    Site Not Available

  • Alta Bates Sutter Medical Center, East Bay Hospital

    Oakland, California 94609
    United States

    Site Not Available

  • St. Helena Hospital, Adventist Heart Institute

    Saint Helena, California 94574
    United States

    Site Not Available

  • St. Helena Hospital, Adventist Heart Institute

    St. Helena, California 94574
    United States

    Site Not Available

  • Stanford University Department of CV medicine

    Stanford, California 94305
    United States

    Site Not Available

  • Shands at the University of Florida

    Gainesville, Florida 32610
    United States

    Site Not Available

  • Orlando Heart Institute

    Orlando, Florida 32806
    United States

    Site Not Available

  • Sarasota Memorial Hospital

    Sarasota, Florida 34239
    United States

    Site Not Available

  • Saint Alphonsus Regional Medical Center

    Boise, Idaho 83706
    United States

    Site Not Available

  • OSF St. Anthony Hospital

    Rockford, Illinois
    United States

    Site Not Available

  • The Christ Hospital

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Tri Health Hosptial - Good Samaritan and Bethesda North Hospitals

    Cincinnati, Ohio
    United States

    Site Not Available

  • Pinnacle Health

    Harrisburg, Pennsylvania 17104
    United States

    Site Not Available

  • Sentara Cardiovascular Research Institute

    Norfolk, Virginia 23507
    United States

    Site Not Available

  • Virginia Commonwealth University

    Richmond, Virginia 23298
    United States

    Site Not Available

  • Aspirus Research Institute

    Wausau, Wisconsin 54401
    United States

    Site Not Available

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