search
Back to results

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

Primary Purpose

Persistent Atrial Fibrillation

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax
Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering
Sponsored by
AtriCure, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Persistent Atrial Fibrillation focused on measuring Atrial Fibrillation, Convergent Procedure, Combined Epicardial/ Endocardial Ablation, Hybrid Procedure, Radiofrequency Ablation, Arrhythmia, RF Ablation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Grandview Medical Center
  • Heart Center Research LLC
  • Rose Medical Center / Medical Center of Aurora
  • Medstar Washington Hospital Center
  • St. Vincent's HealthCare
  • Mt Sinai Medical Center
  • Palm Beach Gardens Medical Center
  • Emory University - St. Joseph's Hospital
  • St. Vincent Medical Group Inc.
  • Cardiovascular Research Foundation of Louisiana
  • Lahey Clinic
  • Genesys Regional Medical Center
  • Cardiology Associates Research, LLC
  • Maimonides Medical Center
  • Staten Island University Hospital
  • Duke University Medical Center
  • East Carolina University - Vidant Medical Center
  • Wake Medical Center / Cary Research Group
  • Summa Health System
  • Riverside Hospital / OhioHealth
  • UPMC Pinnacle Hospitals
  • Allegheny-Singer Research Institute
  • Austin Heart PLLC
  • STAR Clinical Trials LLC
  • Virginia Cardiovascular Specialists
  • St. Bartholomew's Hospital
  • Guy's and St. Thomas Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Convergent Procedure

Standalone Endocardial Catheter Ablation

Arm Description

Procedure/Surgery: Convergent Procedure using EPi-Sense-AF Guided Coagulation System with Endocardial Catheter Ablation Treatment

Procedure/Surgery: Endocardial Catheter Ablation Treatment

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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
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.
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.
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.
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.
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.
Change in Left Atrial Diameter
Change in Left Atrial Diameter at 6 months from baseline.

Full Information

First Posted
November 7, 2013
Last Updated
August 7, 2023
Sponsor
AtriCure, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT01984346
Brief Title
CONVERGE - Epi/Endo Ablation For Treatment of Persistent Atrial Fibrillation(AF)
Acronym
CONVERGE
Official Title
Convergence Of Epicardial And Endocardial Radiofrequency (RF) Ablation For The Treatment Of Symptomatic Persistent AF
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 2013 (undefined)
Primary Completion Date
August 2019 (Actual)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AtriCure, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Atrial Fibrillation
Keywords
Atrial Fibrillation, Convergent Procedure, Combined Epicardial/ Endocardial Ablation, Hybrid Procedure, Radiofrequency Ablation, Arrhythmia, RF Ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2:1 randomized (Convergent Procedure versus standalone endocardial catheter ablation) multi-center pivotal clinical study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
170 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Convergent Procedure
Arm Type
Experimental
Arm Description
Procedure/Surgery: Convergent Procedure using EPi-Sense-AF Guided Coagulation System with Endocardial Catheter Ablation Treatment
Arm Title
Standalone Endocardial Catheter Ablation
Arm Type
Active Comparator
Arm Description
Procedure/Surgery: Endocardial Catheter Ablation Treatment
Intervention Type
Device
Intervention Name(s)
AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax
Other Intervention Name(s)
Epicardial EPi-Sense-AF Guided Coagulation System combined with endocardial RF catheter ablation
Intervention Description
Convergent Epicardial Endocardial Ablation Procedure
Intervention Type
Device
Intervention Name(s)
Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering
Intervention Description
Endocardial Catheter Ablation Procedure
Primary Outcome Measure Information:
Title
Primary Efficacy Endpoint - Number of Participants to Achieve Freedom From AF/AT/AFL.
Description
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.
Time Frame
12 Months
Title
Primary Safety Analysis
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Secondary Safety Endpoint - Serious Adverse Events Through 12 Months Post-procedure.
Description
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.
Time Frame
12 month
Title
Number of Patients With AF Burden Reduction of at Least 90% at 12 Months Compared to Baseline
Description
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.
Time Frame
12 Months
Title
AF Freedom Through 12 Months- Absent of an Increased Dose or New Class I/III AAD's.
Description
Number of patients with AF Freedom through 12 Months (ITT Population) absent of an increased dose or new class I/III AAD's
Time Frame
12 Months
Title
Number of Subjects With AF Burden Reduction of at Least 90% at 12 Months Relative to Baseline, Regardless of Class I/III AADs.
Description
Number of subjects with AF freedom through 12 months achieved in the EPi-Sense group compared to subjects in the Catheter Ablation group.
Time Frame
12 Months
Title
Change in Atrial Fibrillation Severity Scale (AFSS)
Description
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.
Time Frame
12 months
Title
Change in Quality of Life Physical Health Composite Scores Using Short Form Health Survey (SF-36)
Description
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.
Time Frame
12 Months
Title
Quality of Life-Change in SF-36 Mental Health Composite Score Using Short Form Survey (SF-36)
Description
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.
Time Frame
12 months
Title
Change in 6-Minute Walk Score
Description
6 minute walk score was measured by change from baseline compared to 12-months post-procedure between the EPi-Sense and Catheter Ablation groups.
Time Frame
12 months
Title
Change in Left Atrial Diameter
Description
Change in Left Atrial Diameter at 6 months from baseline.
Time Frame
6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David DeLurgio, MD
Organizational Affiliation
Emory St Joseph's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grandview Medical Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35243
Country
United States
Facility Name
Heart Center Research LLC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Rose Medical Center / Medical Center of Aurora
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Medstar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
St. Vincent's HealthCare
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Mt Sinai Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Palm Beach Gardens Medical Center
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33410
Country
United States
Facility Name
Emory University - St. Joseph's Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
St. Vincent Medical Group Inc.
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Cardiovascular Research Foundation of Louisiana
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Lahey Clinic
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Genesys Regional Medical Center
City
Grand Blanc
State/Province
Michigan
ZIP/Postal Code
48439
Country
United States
Facility Name
Cardiology Associates Research, LLC
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Maimonides Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11219
Country
United States
Facility Name
Staten Island University Hospital
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
East Carolina University - Vidant Medical Center
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Wake Medical Center / Cary Research Group
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
Facility Name
Summa Health System
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
Facility Name
Riverside Hospital / OhioHealth
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
UPMC Pinnacle Hospitals
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17101
Country
United States
Facility Name
Allegheny-Singer Research Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Austin Heart PLLC
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
STAR Clinical Trials LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Virginia Cardiovascular Specialists
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States
Facility Name
St. Bartholomew's Hospital
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
Guy's and St. Thomas Hospital
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33185144
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs