ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01984346
Recruitment Status : Active, not recruiting
First Posted : November 14, 2013
Last Update Posted : September 25, 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)
Actual 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 : August 2019
Estimated Study Completion Date : August 2024

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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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


  Hide Study Locations
Locations
United States, Alabama
Grandview Medical Center
Birmingham, Alabama, United States, 35243
Heart Center Research LLC
Huntsville, Alabama, United States, 35801
United States, Colorado
Rose Medical Center / Medical Center of Aurora
Denver, Colorado, United States, 80220
United States, District of Columbia
Medstar Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
St. Vincent's HealthCare
Jacksonville, Florida, United States, 32204
Mt Sinai Medical Center
Miami Beach, Florida, United States, 33140
Palm Beach Gardens Medical Center
Palm Beach Gardens, Florida, United States, 33410
United States, Georgia
Emory University - St. Joseph's Hospital
Atlanta, Georgia, United States, 30342
United States, Indiana
St. Vincent Medical Group Inc.
Indianapolis, Indiana, United States, 46260
United States, Louisiana
Cardiovascular Research Foundation of Louisiana
Baton Rouge, Louisiana, United States, 70808
United States, Massachusetts
Lahey Clinic
Burlington, Massachusetts, United States, 01805
United States, Michigan
Genesys Regional Medical Center
Grand Blanc, Michigan, United States, 48439
United States, Mississippi
Cardiology Associates Research, LLC
Tupelo, Mississippi, United States, 38801
United States, New York
Maimonides Medical Center
Brooklyn, New York, United States, 11219
Staten Island University Hospital
Staten Island, New York, United States, 10305
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
East Carolina University - Vidant Medical Center
Greenville, North Carolina, United States, 27834
Wake Medical Center / Cary Research Group
Raleigh, North Carolina, United States, 27518
United States, Ohio
Summa Health System
Akron, Ohio, United States, 44304
Riverside Hospital / OhioHealth
Columbus, Ohio, United States, 43214
United States, Pennsylvania
UPMC Pinnacle Hospitals
Harrisburg, Pennsylvania, United States, 17101
Allegheny-Singer Research Institute
Pittsburgh, Pennsylvania, United States, 15212
United States, Texas
Austin Heart PLLC
Austin, Texas, United States, 78756
STAR Clinical Trials LLC
San Antonio, Texas, United States, 78229
United States, Virginia
Virginia Cardiovascular Specialists
Richmond, Virginia, United States, 23229
United Kingdom
St. Bartholomew's Hospital
London, United Kingdom, E1 1BB
Guy's and St. Thomas Hospital
London, United Kingdom, SE1 7EH
Sponsors and Collaborators
AtriCure, Inc.
Investigators
Principal Investigator: David DeLurgio, MD Emory St Joseph's Hospital

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: September 25, 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