CONVERGE - Epi/Endo Ablation For Treatment of Persistent Atrial Fibrillation(AF)
NCT ID: NCT01984346
Last Updated: 2023-11-13
Study Results
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View full resultsBasic Information
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COMPLETED
NA
170 participants
INTERVENTIONAL
2013-12-31
2023-10-31
Brief Summary
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Detailed Description
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The primary efficacy endpoint is success or failure to be AF/AT/AFL free absent class I and III AADs except for a previously failed or intolerant class I or III AAD with no increase in dosage following the 3-month blanking period through the 12-month post procedure follow-up visit.
The primary safety endpoint is the incidence of major adverse events (MAEs) listed in the protocol for subjects undergoing the convergent procedure for the procedural to 30-day post procedure time period.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Convergent Procedure
Procedure/Surgery: Convergent Procedure using EPi-Sense-AF Guided Coagulation System with Endocardial Catheter Ablation Treatment
AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax
Convergent Epicardial Endocardial Ablation Procedure
Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering
Endocardial Catheter Ablation Procedure
Standalone Endocardial Catheter Ablation
Procedure/Surgery: Endocardial Catheter Ablation Treatment
Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering
Endocardial Catheter Ablation Procedure
Interventions
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AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax
Convergent Epicardial Endocardial Ablation Procedure
Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering
Endocardial Catheter Ablation Procedure
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Left atrium \< 6.0 cm
* Refractory or intolerant to one AAD (class I and/or III)
* Documentation of persistent AF
* Provided written informed consent
Exclusion Criteria
* Left ventricular ejection fraction \< 40%
* Pregnant or planning to become pregnant during study
* Co-morbid medical conditions that limit one year life expectancy
* Previous cardiac surgery
* History of pericarditis
* Previous cerebrovascular accident (CVA), excluding fully resolved transient Ischemic attack (TIA)
* Patients who have active infection or sepsis
* Patients with esophageal ulcers strictures and varices
* Patients with renal dysfunction who are not on dialysis
* Patients who are contraindicated for anticoagulants
* Patients who are being treated for ventricular arrhythmias
* Patients who have had a previous left atrial catheter ablation for AF
* Patients with existing Implantable Cardioverter-Defibrillator (ICDs)
* Current participation in another clinical investigation of a medical device or a drug, or recent participation in such a study within 30 days prior to study enrollment
* Not competent to legally represent him or herself
18 Years
80 Years
ALL
No
Sponsors
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AtriCure, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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David DeLurgio, MD
Role: PRINCIPAL_INVESTIGATOR
Emory St Joseph's Hospital
Locations
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Grandview Medical Center
Birmingham, Alabama, United States
Heart Center Research LLC
Huntsville, Alabama, United States
Rose Medical Center / Medical Center of Aurora
Denver, Colorado, United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States
St. Vincent's HealthCare
Jacksonville, Florida, United States
Mt Sinai Medical Center
Miami Beach, Florida, United States
Palm Beach Gardens Medical Center
Palm Beach Gardens, Florida, United States
Emory University - St. Joseph's Hospital
Atlanta, Georgia, United States
St. Vincent Medical Group Inc.
Indianapolis, Indiana, United States
Cardiovascular Research Foundation of Louisiana
Baton Rouge, Louisiana, United States
Lahey Clinic
Burlington, Massachusetts, United States
Genesys Regional Medical Center
Grand Blanc, Michigan, United States
Cardiology Associates Research, LLC
Tupelo, Mississippi, United States
Maimonides Medical Center
Brooklyn, New York, United States
Staten Island University Hospital
Staten Island, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
East Carolina University - Vidant Medical Center
Greenville, North Carolina, United States
Wake Medical Center / Cary Research Group
Raleigh, North Carolina, United States
Summa Health System
Akron, Ohio, United States
Riverside Hospital / OhioHealth
Columbus, Ohio, United States
UPMC Pinnacle Hospitals
Harrisburg, Pennsylvania, United States
Allegheny-Singer Research Institute
Pittsburgh, Pennsylvania, United States
Austin Heart PLLC
Austin, Texas, United States
STAR Clinical Trials LLC
San Antonio, Texas, United States
Virginia Cardiovascular Specialists
Richmond, Virginia, United States
St. Bartholomew's Hospital
London, , United Kingdom
Guy's and St. Thomas Hospital
London, , United Kingdom
Countries
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References
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Gill J, Crossen KJ, Blauth C, Kerendi F, Oza SR, Magnano AR, Mostovych MA, Halkos ME, Tschopp D, Osorio J, Tabereaux P, Boedefeld W, Civello K, Ahsan S, Yap J, Billakanty S, Duff S, Costantini O, Espinal E, Kiser A, Shults C, Pederson D, Garrison J, Gilligan DM, Link MG, Kowalski M, Stees C, Sperling JS, Jacobowitz I, Yang F, Greenberg YJ, De Lurgio DB. Atrial fibrillation symptom reduction and improved quality of life following the hybrid convergent procedure: a CONVERGE trial subanalysis. Ann Cardiothorac Surg. 2024 Mar 29;13(2):155-164. doi: 10.21037/acs-2023-afm-15. Epub 2023 Aug 29.
DeLurgio DB, Crossen KJ, Gill J, Blauth C, Oza SR, Magnano AR, Mostovych MA, Halkos ME, Tschopp DR, Kerendi F, Taigen TL, Shults CC, Shah MH, Rajendra AB, Osorio J, Silver JS, Hook BG, Gilligan DM, Calkins H. Hybrid Convergent Procedure for the Treatment of Persistent and Long-Standing Persistent Atrial Fibrillation: Results of CONVERGE Clinical Trial. Circ Arrhythm Electrophysiol. 2020 Dec;13(12):e009288. doi: 10.1161/CIRCEP.120.009288. Epub 2020 Nov 13.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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IDE Number G130084
Identifier Type: OTHER
Identifier Source: secondary_id
VAL-1200
Identifier Type: -
Identifier Source: org_study_id
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