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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by nContact Surgical Inc.
Sponsor:
Information provided by (Responsible Party):
nContact Surgical Inc.
ClinicalTrials.gov Identifier:
NCT01984346
First received: November 7, 2013
Last updated: March 5, 2014
Last verified: March 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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 nContact Surgical 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 ] [ Designated as safety issue: No ]
    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: June 2020
Estimated Primary Completion Date: June 2016 (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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years; < 80 years
  • Left atrium < 6.0 cm
  • History of AF for ≤ 10 years
  • 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 Permanent Pacemakers (PPMs) and 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: Jagruti Vyas, BS 919-655-1354 jvyas@ncontactinc.com
Contact: James G Whayne, MS 919-655-1561 jwhayne@ncontactinc.com

Locations
United States, Indiana
St. Vincent Medical Group Inc. Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Sara Simpkiss    317-583-6115    sara.simpkiss@stvincent.org   
Contact: Andy Scroggs    317-338-9380    rascrogg@stvincent.org   
Principal Investigator: Jeffrey Olson, DO         
Principal Investigator: Peter Walts, MD         
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, 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, Pennsylvania
Allegheny-Singer Research Institute Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Cheryl Snyder, RN BSN CCRC    412-359-3802    csnyder1@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         
United States, Virginia
Virginia Cardiovascular Specialists Recruiting
Richmond, Virginia, United States, 23229
Contact: Anne Adams, BS    804-521-5828    aadams@vacardio.com   
Contact: Laura Puckett, RN    804-521-5829    lpuckett@vacardio.com   
Principal Investigator: John Onufer, MD         
Sponsors and Collaborators
nContact Surgical Inc.
  More Information

No publications provided

Responsible Party: nContact Surgical Inc.
ClinicalTrials.gov Identifier: NCT01984346     History of Changes
Other Study ID Numbers: VAL-1200, IDE Number G130084
Study First Received: November 7, 2013
Last Updated: March 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by nContact Surgical 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 July 23, 2014