Pivotal Study Of A Dual Epicardial & Endocardial Procedure (DEEP) Approach
NCT ID: NCT02393885
Last Updated: 2024-12-19
Study Results
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View full resultsBasic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2015-02-28
2024-04-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System, Endocardial Ablation
Interventions
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AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System, Endocardial Ablation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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.
18 Years
75 Years
ALL
No
Sponsors
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AtriCure, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Kenneth Ellenbogen, MD
Role: PRINCIPAL_INVESTIGATOR
VCU
Vigneshwar Kasirajan, MD
Role: PRINCIPAL_INVESTIGATOR
VCU
Ali Khoynezhad, MD
Role: PRINCIPAL_INVESTIGATOR
MemorialCare Long Beach Medical Ctr
Locations
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Long Beach Memorial Medical Center
Long Beach, California, United States
Cedars-Sinai Heart Institute
Los Angeles, California, United States
Alta Bates Sutter Medical Center, East Bay Hospital
Oakland, California, United States
St. Helena Hospital, Adventist Heart Institute
St. Helena, California, United States
Stanford University Department of CV medicine
Stanford, California, United States
Shands at the University of Florida
Gainesville, Florida, United States
Orlando Heart Institute
Orlando, Florida, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
Saint Alphonsus Regional Medical Center
Boise, Idaho, United States
The Christ Hospital
Cincinnati, Ohio, United States
Tri Health Hosptial - Good Samaritan and Bethesda North Hospitals
Cincinnati, Ohio, United States
Pinnacle Health
Harrisburg, Pennsylvania, United States
Sentara Cardiovascular Research Institute
Norfolk, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Aspirus Research Institute
Wausau, Wisconsin, United States
Universitair Ziekenhuis Brussel (UZ Brussels)
Brussels, , Belgium
Academic Medical Center (AMC)
Amsterdam, , Netherlands
Countries
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References
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Ellenbogen KA, Khoynezhad A, La Meir M, de Asmundis C, Koneru JN, Johnkoski J, Rist K, Mumtaz M, Link MG, de Groot JR, Driessen AHG, Lee MY, Hoff SJ, Bello D, Dunnington G, Eisenberg S, Vloka M, Taylor BJ, Jones SD, Philpott JM, Beaver TM, Miles WM, Khan JH, Kang S, Gandhi GD, Okum EJ, Badhwar N, Baykaner T, Lee AM, Vesco PA, Smith JM, Gaynor S, Frazier K, Lee RJ, Kasirajan V. Dual Epicardial and Endocardial Procedure (DEEP) for Persistent or Longstanding Persistent Atrial Fibrillation. Circ Arrhythm Electrophysiol. 2025 Oct;18(10):e013692. doi: 10.1161/CIRCEP.125.013692. Epub 2025 Sep 30.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CP2014-1
Identifier Type: -
Identifier Source: org_study_id