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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 by AtriCure, Inc.
Sponsor:
Information provided by (Responsible Party):
AtriCure, Inc.
ClinicalTrials.gov Identifier:
NCT01984346
First received: November 7, 2013
Last updated: February 23, 2017
Last verified: February 2017
  Purpose
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 Intervention
Persistent Atrial Fibrillation
Device: Convergent Procedure EPi-Sense-AF Guided Coagulation System
Device: Endocardial Catheter Ablation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Convergence Of Epicardial And Endocardial Radiofrequency (RF) Ablation For The Treatment Of Symptomatic Persistent AF

Resource links provided by NLM:


Further study details as provided by AtriCure, Inc.:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 153
Study Start Date: December 2013
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Convergent Procedure
Combined Epicardial / Endocardial Ablation
Device: Convergent Procedure EPi-Sense-AF Guided Coagulation System
Combined Epicardial Endocardial Ablation
Other Name: EPi-Sense-AF Guided Coagulation System
Active Comparator: Standalone Endocardial Catheter Ablation
Endocardial Catheter Ablation only
Device: Endocardial Catheter Ablation
Endocardial Catheter Ablation only
Other Name: Irrigated Endocardial Catheters

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01984346

Contacts
Contact: Tammy Davis, BSN 513-644-4211 tdavis@atricure.com
Contact: Shana Zink, BS 513-755-4562 szink@atricure.com

Locations
United States, Alabama
Heart Center Research LLC Recruiting
Huntsville, Alabama, United States, 35801
Contact: Jessica Marsh, RN    256-519-8276    jmarsh@theheartcenter.md   
Contact: Cynthia Royster    256-519-8322    croyster@theheartcenter.md   
Principal Investigator: Paul Tabereaux, 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   
Contact: Shilpa Rele    202-877-0805    Shilpa.S.Rele@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         
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   
Contact: Julie Young, LPN    225-765-7660    jyoung@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         
United States, North Carolina
Cary Research Group, LLC/Wake Medical Center Recruiting
Raleigh, North Carolina, United States, 27518
Contact: Melanee Tomasulo, RN BSN    919-622-7301    mtomasulo@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: KeriAnn Shuman, RN    330-253-8195 ext 4246    shumank@summahealth.org   
Principal Investigator: Tyler Taigen, MD         
Riverside Hospital / OhioHealth Recruiting
Columbus, Ohio, United States, 43214
Contact: Rose Fischer, BSN       rose.fischer@ohiohealth.com   
Principal Investigator: Sreedhar Billakanty, MD         
United States, Pennsylvania
Allegheny-Singer Research Institute Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Kenneth Rayl, BS, CCRC    412-359-6860    kray@wpahs.org   
Principal Investigator: Amit Thosani, MD         
United States, Texas
Austin Heart PLLC Recruiting
Austin, Texas, United States, 78756
Contact: Janet Hatch, CRC    512-421-3860    janet.hatch@hcahealthcare.com   
Principal Investigator: David Tschopp, MD         
STAR Clinical Trials LLC Recruiting
San Antonio, Texas, United States, 78229
Contact: DD Castillo    210-614-7827    DDCastillo@STARClinicalTrials.com   
Principal Investigator: David Pederson, MD         
United States, Virginia
Virginia Cardiovascular Specialists Recruiting
Richmond, Virginia, United States, 23229
Contact: Anne Adams, BS    804-323-4029 ext 210    aadams@vacardio.com   
Contact: Laura Puckett, RN    804-916-6317    lpuckett@vacardio.com   
Principal Investigator: David Gilligan, MD         
Sponsors and Collaborators
AtriCure, Inc.
  More Information

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 )
Study First Received: November 7, 2013
Last Updated: February 23, 2017

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

ClinicalTrials.gov processed this record on March 23, 2017