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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01984346
Recruitment Status : Active, not recruiting
First Posted : November 14, 2013
Results First Posted : February 10, 2022
Last Update Posted : March 14, 2022
Sponsor:
Information provided by (Responsible Party):
AtriCure, Inc.

Tracking Information
First Submitted Date  ICMJE November 7, 2013
First Posted Date  ICMJE November 14, 2013
Results First Submitted Date  ICMJE August 12, 2021
Results First Posted Date  ICMJE February 10, 2022
Last Update Posted Date March 14, 2022
Study Start Date  ICMJE December 2013
Actual Primary Completion Date August 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 14, 2022)
  • Primary Efficacy Endpoint - Number of Participants to Achieve Freedom From AF/AT/AFL. [ Time Frame: 12 Months ]
    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 [ Time Frame: 30 days ]
    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.
Original 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2022)
  • Secondary Safety Endpoint - Serious Adverse Events Through 12 Months Post-procedure. [ Time Frame: 12 month ]
    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 [ Time Frame: 12 Months ]
    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. [ Time Frame: 12 Months ]
    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. [ Time Frame: 12 Months ]
    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) [ Time Frame: 12 months ]
    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) [ Time Frame: 12 Months ]
    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 composite score based on eight subscales: (1) limitations in physical activities because of health problems; (3) limitations in usual role activities because of physical health problems; (4) bodily pain; (5) vitality (energy and fatigue); and (6) 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) [ Time Frame: 12 months ]
    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 and mental composite score based on eight subscales: (1) limitations in physical activities because of health problems; (3) limitations in usual role activities because of physical health problems; (4) bodily pain; (5) general mental health (psychological distress and well-being); (6) limitations in usual role activities because of emotional problems; (7) vitality (energy and fatigue); and (8) 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 [ Time Frame: 12 months ]
    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 [ Time Frame: 6 Months ]
    Change in Left Atrial Diameter at 6 months from baseline.
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: Parallel Assignment
Intervention Model Description:
2:1 randomized (Convergent Procedure versus standalone endocardial catheter ablation) multi-center pivotal clinical study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Persistent Atrial Fibrillation
Intervention  ICMJE
  • Device: AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax
    Convergent Epicardial Endocardial Ablation Procedure
    Other Name: 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
Study Arms  ICMJE
  • Experimental: Convergent Procedure
    Procedure/Surgery: Convergent Procedure using EPi-Sense-AF Guided Coagulation System with Endocardial Catheter Ablation Treatment
    Interventions:
    • 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
  • Active Comparator: Standalone Endocardial Catheter Ablation
    Procedure/Surgery: Endocardial Catheter Ablation Treatment
    Intervention: Device: Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering
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.

*   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: January 14, 2022)
170
Original Estimated Enrollment  ICMJE
 (submitted: November 13, 2013)
153
Estimated Study Completion Date  ICMJE August 2024
Actual 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 January 2022

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