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

Persistent Atrial Fibrillation Clinical Trial

— CONVERGE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01984346
• Other study ID #: VAL-1200
• Secondary ID: IDE Number G1300
• Status: Completed
• Phase: N/A
• Start date: December 2013
• Est. completion date: October 2023

Study information

• Verified date: November 2023
• Source: AtriCure, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: October 2023
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

Device:
• AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax
Convergent Epicardial Endocardial Ablation Procedure
• Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering
Endocardial Catheter Ablation Procedure

Locations

Country	Name	City	State
United Kingdom	Guy's and St. Thomas Hospital	London
United Kingdom	St. Bartholomew's Hospital	London
United States	Summa Health System	Akron	Ohio
United States	Emory University - St. Joseph's Hospital	Atlanta	Georgia
United States	Austin Heart PLLC	Austin	Texas
United States	Cardiovascular Research Foundation of Louisiana	Baton Rouge	Louisiana
United States	Grandview Medical Center	Birmingham	Alabama
United States	Maimonides Medical Center	Brooklyn	New York
United States	Lahey Clinic	Burlington	Massachusetts
United States	Riverside Hospital / OhioHealth	Columbus	Ohio
United States	Rose Medical Center / Medical Center of Aurora	Denver	Colorado
United States	Duke University Medical Center	Durham	North Carolina
United States	Genesys Regional Medical Center	Grand Blanc	Michigan
United States	East Carolina University - Vidant Medical Center	Greenville	North Carolina
United States	UPMC Pinnacle Hospitals	Harrisburg	Pennsylvania
United States	Heart Center Research LLC	Huntsville	Alabama
United States	St. Vincent Medical Group Inc.	Indianapolis	Indiana
United States	St. Vincent's HealthCare	Jacksonville	Florida
United States	Mt Sinai Medical Center	Miami Beach	Florida
United States	Palm Beach Gardens Medical Center	Palm Beach Gardens	Florida
United States	Allegheny-Singer Research Institute	Pittsburgh	Pennsylvania
United States	Wake Medical Center / Cary Research Group	Raleigh	North Carolina
United States	Virginia Cardiovascular Specialists	Richmond	Virginia
United States	STAR Clinical Trials LLC	San Antonio	Texas
United States	Staten Island University Hospital	Staten Island	New York
United States	Cardiology Associates Research, LLC	Tupelo	Mississippi
United States	Medstar Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
AtriCure, Inc.

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in Left Atrial Diameter	Change in Left Atrial Diameter at 6 months from baseline.	6 Months