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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 : Active, not recruiting
First Posted : November 14, 2013
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
AtriCure, Inc.

Tracking Information
First Submitted Date  ICMJE November 7, 2013
First Posted Date  ICMJE November 14, 2013
Last Update Posted Date September 25, 2018
Study Start Date  ICMJE December 2013
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01984346 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CONVERGE - Epi/Endo Ablation For Treatment of Persistent Atrial Fibrillation(AF)
Official Title  ICMJE Convergence Of Epicardial And Endocardial Radiofrequency (RF) Ablation For The Treatment Of Symptomatic Persistent AF
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).
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Persistent Atrial Fibrillation
Intervention  ICMJE
  • Device: Convergent Procedure EPi-Sense-AF Guided Coagulation System
    Convergent Epicardial Endocardial Ablation Procedure
    Other Name: EPi-Sense-AF Guided Coagulation System
  • Device: Endocardial Catheter Ablation
    Endocardial Catheter Ablation only
    Other Name: Irrigated Endocardial Catheters
Study Arms  ICMJE
  • Experimental: Convergent Procedure
    Convergent Procedure EPi-Sense-AF Guided Coagulation System
    Intervention: Device: Convergent Procedure EPi-Sense-AF Guided Coagulation System
  • Active Comparator: Standalone Endocardial Catheter Ablation
    Endocardial Catheter Ablation Treatment
    Intervention: Device: Endocardial Catheter Ablation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 13, 2013)
153
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2024
Estimated Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01984346
Other Study ID Numbers  ICMJE VAL-1200
IDE Number G130084 ( Other Identifier: CDRH )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party AtriCure, Inc.
Study Sponsor  ICMJE AtriCure, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David DeLurgio, MD Emory St Joseph's Hospital
PRS Account AtriCure, Inc.
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP