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

April 3, 2023 updated by: AtriCure, Inc.

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
        • Universitair Ziekenhuis Brussel (UZ Brussels)
  • Netherlands
      • Amsterdam, Netherlands
        • Academic Medical Center (AMC)
  • United States
    • California
      • Long Beach, California, United States, 90806
        • Long Beach Memorial Medical Center
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Heart Institute
      • Oakland, California, United States, 94609
        • Alta Bates Sutter Medical Center, East Bay Hospital
      • Saint Helena, California, United States, 94574
        • St. Helena Hospital, Adventist Heart Institute
      • Stanford, California, United States, 94305
        • Stanford University Department of CV medicine
    • Florida
      • Gainesville, Florida, United States, 32610
        • Shands at the University of Florida
      • Orlando, Florida, United States, 32806
        • Orlando Heart Institute
      • Sarasota, Florida, United States, 34239
        • Sarasota Memorial Hospital
    • Idaho
      • Boise, Idaho, United States, 83706
        • Saint Alphonsus Regional Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Christ Hospital
      • Cincinnati, Ohio, United States
        • Tri Health Hosptial - Good Samaritan and Bethesda North Hospitals
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17104
        • Pinnacle Health
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Sentara Cardiovascular Research Institute
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University
    • Wisconsin
      • Wausau, Wisconsin, United States, 54401
        • Aspirus Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 3 months
  6. Undergone prior cardiothoracic surgery, previous thorax trauma which resulted in a pneumothorax 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 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 >40
  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.
  28. Pre-existing esophageal condition that required (or requires) endoscopic therapy or surgical treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Irrigated Endocardial Catheters

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 months post the Endocaridal Ablation Procedure through the 12 month follow-up visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AtriCure, Inc.

Investigators

  • Principal Investigator: Kenneth Ellenbogen, MD, VCU
  • Principal Investigator: Vigneshwar Kasirajan, MD, VCU
  • Principal Investigator: Ali Khoynezhad, MD, MemorialCare Long Beach Medical Ctr

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2015

Primary Completion (Anticipated)

November 1, 2024

Study Completion (Anticipated)

December 1, 2027

Study Registration Dates

First Submitted

March 16, 2015

First Submitted That Met QC Criteria

March 16, 2015

First Posted (Estimate)

March 20, 2015

Study Record Updates

Last Update Posted (Actual)

April 4, 2023

Last Update Submitted That Met QC Criteria

April 3, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP2014-1

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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