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

This study has suspended participant recruitment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02393885
First Posted: March 20, 2015
Last Update Posted: June 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AtriCure, Inc.
  Purpose
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

Condition Intervention Phase
Atrial Fibrillation Persistent or Longstanding Persistent Atrial Fibrillation Device: AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System, Endocardial Ablation Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pivotal Study Of A Dual Epicardial & Endocardial Procedure (DEEP) Approach for Treatment of Subjects With Persistent or Long Standing Persistent Atrial Fibrillation With Radiofrequency Ablation

Resource links provided by NLM:


Further study details as provided by AtriCure, Inc.:

Primary Outcome Measures:
  • Freedom from any documented AF, atrial flutter, or atrial tachycardia lasting >30 seconds in duration through the 12 month follow-up visit in the absence of Class I or III AADs (with the exception of previously failed [ Time Frame: 6 months post the Endocaridal Ablation Procedure through the 12 month follow-up visit ]

Estimated Enrollment: 220
Actual Study Start Date: February 2015
Estimated Study Completion Date: November 2021
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System
AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System at day 1 of surgical procedure followed by endocardial catheter ablation procedure to occur at approximately 90 days after day 1 of surgical procedure.
Device: AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System, Endocardial Ablation
Other Name: Irrigated Endocardial Catheters

Detailed 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

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 6 months
  6. Undergone prior cardiothoracic surgery, previous thorax trauma which resulted in a pneumothorax or hemothorax.
  7. Sleep apnea, home oxygen therapy, 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 being treated for arrhythmias other than atrial fibrillation (AF) or atrial flutter.
  10. Documented history of previous catheter ablation with perforation, history of pericarditis, pericardial effusion, or tamponade.
  11. Structural heart disease requiring surgical treatment (i.e. valve disease requiring repair 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 artery stenosis greater than 80%.
  16. BMI is >35.
  17. Thrombus in the left atrium or the left atrial appendage, determined by echocardiography (either at baseline TTE (or equivalent diagnostic test) or intraoperative 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 poses undue risk to the patient from participating in the endocardial EP procedure.
  20. Documented thromboembolism within the previous six months prior to signing informed consent.
  21. Has the following atrial myxoma, mural thrombus or mural tumor.
  22. A condition or congenital anomaly which prevents required surgical or catheter access.
  23. A co-morbid condition that, in the opinion of the investigator, poses undue risk of general 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 to signing 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's well-being and/or the soundness of this clinical study.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02393885


Locations
United States, California
Cedars-Sinai Heart Institute
Los Angeles, California, United States, 90048
Alta Bates Sutter Medical Center, East Bay Hospital
Oakland, California, United States, 94609
St. Helena Hospital, Adventist Heart Institute
Saint Helena, California, United States, 94574
United States, Florida
Shands at the University of Florida
Gainesville, Florida, United States, 32610
Orlando Heart Institute
Orlando, Florida, United States, 32806
United States, Illinois
OSF St. Anthony Hospital
Rockford, Illinois, United States
United States, Ohio
Tri Health Hosptial - Good Samaritan and Bethesda North Hospitals
Cincinnati, Ohio, United States
United States, Virginia
Sentara Cardiovascular Research Institute
Norfolk, Virginia, United States, 23507
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
United States, Wisconsin
Aspirus Research Institute
Wausau, Wisconsin, United States, 54401
Belgium
Universitair Ziekenhuis Brussel (UZ Brussels)
Brussels, Belgium
Netherlands
Academic Medical Center (AMC)
Amsterdam, Netherlands
Sponsors and Collaborators
AtriCure, Inc.
Investigators
Principal Investigator: Kenneth Ellenbogen, MD VCU
Principal Investigator: Vigneshwar Kasirajan, MD VCU
  More Information

Responsible Party: AtriCure, Inc.
ClinicalTrials.gov Identifier: NCT02393885     History of Changes
Other Study ID Numbers: CP2014-1
First Submitted: March 16, 2015
First Posted: March 20, 2015
Last Update Posted: June 22, 2017
Last Verified: November 2016

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes