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CONVERGE - Epi/Endo Ablation For Treatment of Persistent Atrial Fibrillation(AF) (CONVERGE)

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ClinicalTrials.gov Identifier: NCT01984346
Recruitment Status : Recruiting
First Posted : November 14, 2013
Last Update Posted : June 1, 2018
Sponsor:
Information provided by (Responsible Party):
AtriCure, Inc.

Brief Summary:
This is a multi-center, open label, randomized pivotal study evaluating the safety and efficacy of the EPi-Sense-AF Guided Coagulation System for the treatment of persistent AF patients, refractory or intolerant to at least one Class I and/or III Anti Arrhythmic Drug (AAD).

Condition or disease Intervention/treatment Phase
Persistent Atrial Fibrillation Device: Convergent Procedure EPi-Sense-AF Guided Coagulation System Device: Endocardial Catheter Ablation Not Applicable

Detailed Description:

The objective of this randomized pivotal study is to evaluate the safety and efficacy of the AtriCure EPi-Sense®-AF Guided Coagulation System with VisiTrax® for the treatment of symptomatic persistent Atrial Fibrillation (AF) patients, refractory or intolerant to at least one Class I or Class III anti-arrhythmic drug (AAD). 153 subjects from up to 27 US and 3 OUS sites. Randomized 2:1.

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 153 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Convergence Of Epicardial And Endocardial Radiofrequency (RF) Ablation For The Treatment Of Symptomatic Persistent AF
Study Start Date : December 2013
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Convergent Procedure
Convergent Procedure EPi-Sense-AF Guided Coagulation System
Device: Convergent Procedure EPi-Sense-AF Guided Coagulation System
Convergent Epicardial Endocardial Ablation Procedure
Other Name: EPi-Sense-AF Guided Coagulation System

Active Comparator: Standalone Endocardial Catheter Ablation
Endocardial Catheter Ablation Treatment
Device: Endocardial Catheter Ablation
Endocardial Catheter Ablation only
Other Name: Irrigated Endocardial Catheters




Primary Outcome Measures :
  1. AF/AT/Atrial Flutter(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. [ Time Frame: 12 Months ]
    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 months post procedure follow-up visit.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years; < 80 years
  • 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:

  • Patients requiring concomitant surgery
  • 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

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): NCT01984346


Contacts
Contact: Sue O'Gara, BSN 513-644-4728 sogara@atricure.com
Contact: Nfii Ndikintum, PhD 513-644-8192 nndikintum@atricure.com

  Hide Study Locations
Locations
United States, Alabama
Grandview Medical Center Recruiting
Birmingham, Alabama, United States, 35243
Contact: Susan Thorington, MSN    205-971-7578    sthorington@alcardio.com   
Principal Investigator: Jose Osorio, MD         
Heart Center Research LLC Recruiting
Huntsville, Alabama, United States, 35801
Contact: Samantha Lindsey, RN       mailto:slindsey@theheartcenter.md   
Principal Investigator: Paul Tabereaux, MD         
United States, Colorado
Rose Medical Center / Medical Center of Aurora Recruiting
Denver, Colorado, United States, 80220
Contact: Debbie Dahler, CCRC       Deborah.Dahler2@HealthONEcares.com   
Principal Investigator: Jason Sperling, MD         
United States, District of Columbia
Medstar Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Shine Y. Kim, BSN, RN    202-877-0805    Shine.Y.Kim@medstar.net   
Principal Investigator: Manish Shah, MD         
United States, Florida
St. Vincent's HealthCare Recruiting
Jacksonville, Florida, United States, 32204
Contact: Lisa Joseph, RN       lisa.joseph@jaxhealth.com   
Principal Investigator: Saumil Oza, MD         
Mt Sinai Medical Center Recruiting
Miami Beach, Florida, United States, 33140
Contact: Glenda Ortiz       Glenda.Ortiz@msmc.com   
Principal Investigator: Angelo LaPietra, MD         
Palm Beach Gardens Medical Center Recruiting
Palm Beach Gardens, Florida, United States, 33410
Contact: Elizabeth Wettermann, BSN       ELIZABETH.WETTERMANN@TENETHEALTH.COM   
Principal Investigator: David Weisman, MD         
United States, Georgia
Emory University - St. Joseph's Hospital Recruiting
Atlanta, Georgia, United States, 30342
Contact: Cynthia Barnes, RN    678-843-6093    Cynthia.Barnes@emory.edu   
Principal Investigator: David DeLurgio, MD         
United States, Indiana
St. Vincent Medical Group Inc. Active, not recruiting
Indianapolis, Indiana, United States, 46260
United States, Louisiana
Cardiovascular Research Foundation of Louisiana Recruiting
Baton Rouge, Louisiana, United States, 70808
Contact: Becky Toler, RN, BSN    225-765-7733    btoler@crfla.org   
Principal Investigator: Kenneth Civello, MD         
United States, Massachusetts
Lahey Clinic Recruiting
Burlington, Massachusetts, United States, 01805
Contact: Jean Byrne, RN    781-744-1901    jean.byrne@lahey.org   
Principal Investigator: Bruce G Hook, MD         
United States, Michigan
Genesys Regional Medical Center Recruiting
Grand Blanc, Michigan, United States, 48439
Contact: Sandra Watt, RN    810-606-7713    swatt@genesys.org   
Contact: Virginia Williamson, RN    810-606-7733    vwilliamson@genesys.org   
Principal Investigator: Marc Silver, MD         
United States, Mississippi
Cardiology Associates Research, LLC Recruiting
Tupelo, Mississippi, United States, 38801
Contact: Angela Long, RN    662-377-7571    along@nmhs.net   
Principal Investigator: Karl Crossen, MD         
United States, New York
Maimonides Medical Center Recruiting
Brooklyn, New York, United States, 11219
Contact: Linda Budzilowicz, RNC, MA       lbudzilowicz@maimonidesmed.org   
Principal Investigator: Yisachar Greenberg, MD         
Staten Island University Hospital Recruiting
Staten Island, New York, United States, 10305
Contact: Maria Scibilia, RN - C-CRC    917-617-6004    MScibilia@northwell.edu   
Principal Investigator: Marcin Kowalski, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Greg Tipton, BSN    919-684-4491    greg.tipton@duke.edu   
Principal Investigator: Mani Daneshmand, MD         
East Carolina University - Vidant Medical Center Recruiting
Greenville, North Carolina, United States, 27834
Contact: Brenda Akers, BSN    252-744-8482    AKERSBR@ecu.edu   
Principal Investigator: Andy Kiser, MD         
Wake Medical Center / Cary Research Group Recruiting
Raleigh, North Carolina, United States, 27518
Contact: LaMonica Daniel, BS    919-231-6132    LaDaniel@WakeMed.org   
Principal Investigator: Pavlo Netrebko, MD         
Principal Investigator: Bryon Boulton, MD         
United States, Ohio
Summa Health System Recruiting
Akron, Ohio, United States, 44304
Contact: Jeremy Kick, BSN    330-253-8195 ext 4259    kickj@summahealth.org   
Principal Investigator: Tyler Taigen, MD         
Riverside Hospital / OhioHealth Recruiting
Columbus, Ohio, United States, 43214
Contact: Vickie Hatch, BSN       Vickie.Hatch@ohiohealth.com   
Principal Investigator: Sreedhar Billakanty, MD         
United States, Pennsylvania
UPMC Pinnacle Hospitals Recruiting
Harrisburg, Pennsylvania, United States, 17101
Contact: Regina Hollister, RN    717-731-0101 ext 3152    rhollister@PINNACLEHEALTH.org   
Principal Investigator: Michael G Link, MD         
Principal Investigator: Nikhil P Jaik, MD         
Allegheny-Singer Research Institute Active, not recruiting
Pittsburgh, Pennsylvania, United States, 15212
United States, Texas
Austin Heart PLLC Recruiting
Austin, Texas, United States, 78756
Contact: Shannon Juarez, CRC    512-421-3860    Shannon.Juarez@HCAHealthcare.com   
Principal Investigator: David Tschopp, MD         
STAR Clinical Trials LLC Recruiting
San Antonio, Texas, United States, 78229
Contact: Maria Garcia       mgarcia@starclinicaltrials.com   
Principal Investigator: David Pederson, MD         
United States, Virginia
Virginia Cardiovascular Specialists Recruiting
Richmond, Virginia, United States, 23229
Contact: Kyle Narron, RN       knarron@vacardio.com   
Principal Investigator: David Gilligan, MD         
United Kingdom
St. Bartholomew's Hospital Recruiting
London, United Kingdom, E1 1BB
Contact: Hakam Abbass    020 3765 8890    Hakam.Abbass@bartshealth.nhs.uk   
Principal Investigator: Syed Ahsan, MD         
Guy's and St. Thomas Hospital Recruiting
London, United Kingdom, SE1 7EH
Contact: Emma Atkinson    02071887188 ext 80998    emma.atkinson@gstt.nhs.uk   
Principal Investigator: Jaswinder Gill, MD         
Sponsors and Collaborators
AtriCure, Inc.
Investigators
Principal Investigator: David DeLurgio, MD Emory St Joseph's Hospital

Additional Information:
Responsible Party: AtriCure, Inc.
ClinicalTrials.gov Identifier: NCT01984346     History of Changes
Other Study ID Numbers: VAL-1200
IDE Number G130084 ( Other Identifier: CDRH )
First Posted: November 14, 2013    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by AtriCure, Inc.:
Atrial Fibrillation
Convergent Procedure
Combined Epicardial/ Endocardial Ablation
Hybrid Procedure
Radiofrequency Ablation
Arrhythmia
RF Ablation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes