Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02393885
Recruitment Status : Recruiting
First Posted : March 20, 2015
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
AtriCure, Inc.

Tracking Information
First Submitted Date  ICMJE March 16, 2015
First Posted Date  ICMJE March 20, 2015
Last Update Posted Date May 7, 2019
Actual Study Start Date  ICMJE February 2015
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2015)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02393885 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pivotal Study Of A Dual Epicardial & Endocardial Procedure (DEEP) Approach
Official Title  ICMJE 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
Brief 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
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Atrial Fibrillation
  • Persistent or Longstanding Persistent Atrial Fibrillation
Intervention  ICMJE Device: AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System, Endocardial Ablation
Other Name: Irrigated Endocardial Catheters
Study Arms  ICMJE 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.
Intervention: Device: AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System, Endocardial Ablation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 16, 2015)
220
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2025
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nfii Ndikintum NNdikintum@atricure.com
Contact: Denise Breiner DBreiner@atricure.com
Listed Location Countries  ICMJE Belgium,   Netherlands,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02393885
Other Study ID Numbers  ICMJE CP2014-1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AtriCure, Inc.
Study Sponsor  ICMJE AtriCure, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kenneth Ellenbogen, MD VCU
Principal Investigator: Vigneshwar Kasirajan, MD VCU
Principal Investigator: Ali Khoynezhad, MD MemorialCare Long Beach Medical Ctr
PRS Account AtriCure, Inc.
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP