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

Convergence Of Epicardial And Endocardial Radiofrequency (RF) Ablation For The Treatment Of Symptomatic Persistent AF

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).

Study Overview

• Status: Completed
• Conditions: Persistent Atrial Fibrillation
• Intervention / Treatment: Device: AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax; Device: Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering

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
• Enrollment (Actual): 170
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Convergent Procedure; Procedure/Surgery: Convergent Procedure using EPi-Sense-AF Guided Coagulation System with Endocardial Catheter Ablation Treatment	Device: AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax; Convergent Epicardial Endocardial Ablation Procedure; Other Names: Epicardial EPi-Sense-AF Guided Coagulation System combined with endocardial RF catheter ablation; Device: Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering; Endocardial Catheter Ablation Procedure
Active Comparator: Standalone Endocardial Catheter Ablation; Procedure/Surgery: Endocardial Catheter Ablation Treatment	Device: Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering; Endocardial Catheter Ablation Procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Efficacy Endpoint - Number of Participants to Achieve Freedom From AF/AT/AFL.	This binary primary endpoint measures number of patients to achieve freedom from AF/AT/AFL absent class I and III AADs except for previously failed or intolerant I or III AAD with no increase in dosage following the 3-month blanking period through the 12 months post procedure follow-up visit will be compared between the two treatment groups using a chi-square test using a two-sided alpha of .05 to determine if superiority of the treatment arm is attained.	12 Months
Primary Safety Analysis	The primary safety analysis will measure the number of Major Adverse Events (MAE) collected from the start of the coagulation procedure to 30 days post procedure.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Safety Endpoint - Serious Adverse Events Through 12 Months Post-procedure.	The secondary safety endpoint for the study was the number of participants with serious adverse events (SAEs) in the study through the 12-months post-procedure.	12 month
Number of Patients With AF Burden Reduction of at Least 90% at 12 Months Compared to Baseline	AF Burden Reduction of at Least 90% at 12-Months (ITT Population): The first secondary effectiveness endpoint in the fixed-sequence testing was defined as at least 90% reduction in AF burden, absent of an increased dose or new class I/III AADs, at 12 months compared to baseline.	12 Months
AF Freedom Through 12 Months- Absent of an Increased Dose or New Class I/III AAD's.	Number of patients with AF Freedom through 12 Months (ITT Population) absent of an increased dose or new class I/III AAD's	12 Months
Number of Subjects With AF Burden Reduction of at Least 90% at 12 Months Relative to Baseline, Regardless of Class I/III AADs.	Number of subjects with AF freedom through 12 months achieved in the EPi-Sense group compared to subjects in the Catheter Ablation group.	12 Months
Change in Atrial Fibrillation Severity Scale (AFSS)	Change was calculated as the value at 12 months minus the value at baseline. The University of Toronto's Atrial Fibrillation Severity Scale (AFSS) is a composite score of overall subject-perceived severity, global well-being, atrial fibrillation frequency, and atrial fibrillation duration. The score ranges from 3 to 30, with higher scores indicating greater atrial fibrillation burden.	12 months
Change in Quality of Life Physical Health Composite Scores Using Short Form Health Survey (SF-36)	Change was calculated as the value at 12 months minus the value at baseline. The 36-Item Short Form Health Survey (SF-36) is used to determine a physical composite score based on following subscales: limitations in physical activities because of health problems; limitations in usual role activities because of physical health problems; bodily pain; vitality (energy and fatigue); and general health perceptions. The subscale scores are transformed into a range from 0 to 100, with 0=worst HRQL, 100=best HRQL. The physical component scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score, with higher scores indicating better health status.	12 Months
Quality of Life-Change in SF-36 Mental Health Composite Score Using Short Form Survey (SF-36)	Change was calculated as the value at 12 months minus the value at baseline. The 36-Item Short Form Health Survey (SF-36) is used to determine a mental composite score based on the following subscales: general mental health (psychological distress and well-being); limitations in usual role activities because of emotional problems; and general health perceptions. The subscale scores are transformed into a range from 0 to 100, with 0=worst HRQL, 100=best HRQL. The physical and mental component scores are constructed as a T-score with a mean of 50 and standard deviation of 10 and no minimum or maximum score, with higher scores indicating better health status.	12 months
Change in 6-Minute Walk Score	6 minute walk score was measured by change from baseline compared to 12-months post-procedure between the EPi-Sense and Catheter Ablation groups.	12 months
Change in Left Atrial Diameter	Change in Left Atrial Diameter at 6 months from baseline.	6 Months

Collaborators and Investigators

• Sponsor: AtriCure, Inc.
• Investigators: Principal Investigator: David DeLurgio, MD, Emory St Joseph's Hospital

Publications and helpful links

General Publications

• DeLurgio DB, Crossen KJ, Gill J, Blauth C, Oza SR, Magnano AR, Mostovych MA, Halkos ME, Tschopp DR, Kerendi F, Taigen TL, Shults CC, Shah MH, Rajendra AB, Osorio J, Silver JS, Hook BG, Gilligan DM, Calkins H. Hybrid Convergent Procedure for the Treatment of Persistent and Long-Standing Persistent Atrial Fibrillation: Results of CONVERGE Clinical Trial. Circ Arrhythm Electrophysiol. 2020 Dec;13(12):e009288. doi: 10.1161/CIRCEP.120.009288. Epub 2020 Nov 13.

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): October 1, 2023

Study Registration Dates

• First Submitted: November 7, 2013
• First Submitted That Met QC Criteria: November 13, 2013
• First Posted (Estimated): November 14, 2013

Study Record Updates

• Last Update Posted (Estimated): November 13, 2023
• Last Update Submitted That Met QC Criteria: November 9, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Arrhythmia; Radiofrequency Ablation; Convergent Procedure; Combined Epicardial/ Endocardial Ablation; Hybrid Procedure; RF Ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: VAL-1200; IDE Number G130084 (Other Identifier: CDRH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO