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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 April 2017 by AtriCure, Inc.
Sponsor:
Information provided by (Responsible Party):
AtriCure, Inc.
ClinicalTrials.gov Identifier:
NCT01984346
First received: November 7, 2013
Last updated: June 19, 2017
Last verified: April 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
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

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.

  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

  Show 21 Study Locations
Sponsors and Collaborators
AtriCure, Inc.
Investigators
Principal Investigator: David DeLurgio, MD Emory St Joseph's Hospital
  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: June 19, 2017
Individual Participant Data  
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

ClinicalTrials.gov processed this record on June 22, 2017