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

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ClinicalTrials.gov Identifier: NCT02393885
Recruitment Status : Recruiting
First Posted : March 20, 2015
Last Update Posted : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
AtriCure, Inc.

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

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Persistent or Longstanding Persistent Atrial Fibrillation Device: AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System, Endocardial Ablation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
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
Actual Study Start Date : February 2015
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


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 Name: Irrigated Endocardial Catheters




Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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 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.

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


Contacts
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Contact: Nfii Ndikintum NNdikintum@atricure.com
Contact: Denise Breiner DBreiner@atricure.com

Locations
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United States, California
Long Beach Memorial Medical Center Recruiting
Long Beach, California, United States, 90806
Contact: Elysse Ballon    562-933-2334    EBallon@memorialcare.org   
Contact: Kristine Garcia    562-933-2334    KGarcia@memorialcare.org   
Principal Investigator: Ali Khoynezhad, MD         
Sub-Investigator: Mark Young Lee, MD         
Cedars-Sinai Heart Institute Completed
Los Angeles, California, United States, 90048
Alta Bates Sutter Medical Center, East Bay Hospital Recruiting
Oakland, California, United States, 94609
Contact: Jamie Carroll-Mandelke, RN    510-869-8490    MandelJ@sutterhealth.org   
Principal Investigator: Junaid Khan, MD         
Sub-Investigator: Nitish Badhwar, MD         
Sub-Investigator: Steven Kang, MD         
Sub-Investigator: Frank Chen, MD         
St. Helena Hospital, Adventist Heart Institute Recruiting
Saint Helena, California, United States, 94574
Contact: Jennifer DeBattista, BS, CCRP    707-967-5959    Jennifer.DeBattista@ah.org   
Contact: Carolyn / Carrie Pierce, RN       carolyn.pierce@ah.org   
Principal Investigator: Gansevoort Dunnington, MD         
Sub-Investigator: Peter D. Chang-Sing, MD         
Sub-Investigator: Daniel Kaiser, MD         
Stanford University Department of CV medicine Recruiting
Stanford, California, United States, 94305
Contact: Sara Magee    650-736-8450    smagee2@stanford.edu   
Contact: Gerri O'Riordan    650-725-5597    goriordan@stanford.edu   
Sub-Investigator: Anson Lee, MD         
Sub-Investigator: Nitish Badhwar, MD         
Principal Investigator: Chad Brodt, MD         
United States, Florida
Shands at the University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Jessica Cobb    352-273-7837    Jessica.Cobb@surgery.ufl.edu   
Contact: Breeana Usher    352-273-8728    breeana.usher@surgery.ufl.edu   
Principal Investigator: Thomas Beaver, MD         
Sub-Investigator: William Miles, MD         
Sub-Investigator: Thomas Burkart, MD         
Orlando Heart Institute Recruiting
Orlando, Florida, United States, 32806
Contact: Meghan Tinetti, RN, BSN, CCRP    321-841-3682    Meghan.Tinetti@orlandohealth.com   
Principal Investigator: Steven Hoff, MD         
Sub-Investigator: David Bello, MD         
Sarasota Memorial Hospital Recruiting
Sarasota, Florida, United States, 34239
Contact: Nancy Clapp    941-917-1669    Nancy-Clapp@smh.com   
Principal Investigator: Paul Vesco, MD         
United States, Idaho
Saint Alphonsus Regional Medical Center Recruiting
Boise, Idaho, United States, 83706
Contact: Jennifer Yehle    208-302-0066    Jennifer.Yehle@saintalphonsus.org   
Principal Investigator: Margo Vloka, MD         
Sub-Investigator: Stephen Jones, MD         
Sub-Investigator: Benedict Taylor, MD         
United States, Illinois
OSF St. Anthony Hospital Withdrawn
Rockford, Illinois, United States
United States, Ohio
Tri Health Hosptial - Good Samaritan and Bethesda North Hospitals Active, not recruiting
Cincinnati, Ohio, United States
United States, Pennsylvania
Pinnacle Health Active, not recruiting
Harrisburg, Pennsylvania, United States, 17104
United States, Virginia
Sentara Cardiovascular Research Institute Active, not recruiting
Norfolk, Virginia, United States, 23507
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Andreea Marcu    804-827-1515    andreea.marcu@vcuhealth.org   
Contact: Jinfeng Han    804-828-4281    jinfeng.han@vcuhealth.org   
Principal Investigator: Kenneth Ellenbogen, MD         
Principal Investigator: Vigneshwar Kasirajan, MD         
Sub-Investigator: Jayanthi Koneru, MD         
United States, Wisconsin
Aspirus Research Institute Recruiting
Wausau, Wisconsin, United States, 54401
Contact: Jeff Kaliebe    715-847-2273    jeff.kaliebe@aspirus.com   
Contact: Jennifer Richards, RN    715-847-2273    Jennifer.Richards@apsirus.org   
Principal Investigator: John Johnokski, MD         
Principal Investigator: Kevin Rist, MD         
Sub-Investigator: Andrew Mykytsey, MD         
Sub-Investigator: Ronnie Ortiz, MD         
Belgium
Universitair Ziekenhuis Brussel (UZ Brussels) Recruiting
Brussels, Belgium
Contact: Gudrun Pappaert, RN       Gudrun.Pappaert@uzbrussel.be   
Contact: Brian Roelandt, RN       Brian.Roelandt@uzbrussel.be   
Principal Investigator: Mark La Meir, MD, PhD         
Sub-Investigator: Gian Battista Chiercia, MD         
Sub-Investigator: Carlo de Asmundis, MD         
Netherlands
Academic Medical Center (AMC) Active, not recruiting
Amsterdam, Netherlands
Sponsors and Collaborators
AtriCure, Inc.
Investigators
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Principal Investigator: Kenneth Ellenbogen, MD VCU
Principal Investigator: Vigneshwar Kasirajan, MD VCU
Principal Investigator: Ali Khoynezhad, MD MemorialCare Long Beach Medical Ctr

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Responsible Party: AtriCure, Inc.
ClinicalTrials.gov Identifier: NCT02393885     History of Changes
Other Study ID Numbers: CP2014-1
First Posted: March 20, 2015    Key Record Dates
Last Update Posted: September 9, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes