Clinical trial NCT01984346: CONVERGE - Epi/Endo Ablation For Treatment of Persistent Atrial Fibrillation(AF)
Official title: Convergence Of Epicardial And Endocardial Radiofrequency (RF) Ablation For The Treatment Of Symptomatic Persistent AF
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Persistent Atrial Fibrillation
Keywords: Atrial Fibrillation
Convergent Procedure
Combined Epicardial/ Endocardial Ablation
Hybrid Procedure
Radiofrequency Ablation
Arrhythmia
RF Ablation
Lead sponsor: AtriCure, Inc.
Sponsor class: INDUSTRY
First posted: 2013-11-14
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2:1 randomized (Convergent Procedure versus standalone endocardial catheter ablation) multi-center pivotal clinical study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Primary Efficacy Endpoint - Number of Participants to Achieve Freedom From AF/AT/AFL.
timeFrame: 12 Months
measure: Primary Safety Analysis
timeFrame: 30 days
Secondary outcomes:
measure: Secondary Safety Endpoint - Serious Adverse Events Through 12 Months Post-procedure.
timeFrame: 12 month
measure: Number of Patients With AF Burden Reduction of at Least 90% at 12 Months Compared to Baseline
timeFrame: 12 Months
measure: AF Freedom Through 12 Months- Absent of an Increased Dose or New Class I/III AAD's.
timeFrame: 12 Months
measure: Number of Subjects With AF Burden Reduction of at Least 90% at 12 Months Relative to Baseline, Regardless of Class I/III AADs.
timeFrame: 12 Months
measure: Change in Atrial Fibrillation Severity Scale (AFSS)
timeFrame: 12 months
measure: Change in Quality of Life Physical Health Composite Scores Using Short Form Health Survey (SF-36)
timeFrame: 12 Months
measure: Quality of Life-Change in SF-36 Mental Health Composite Score Using Short Form Survey (SF-36)
timeFrame: 12 months
measure: Change in 6-Minute Walk Score
timeFrame: 12 months
measure: Change in Left Atrial Diameter
timeFrame: 6 Months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Grandview Medical Center
state: Alabama
city: Huntsville
country: United States
facility: Heart Center Research LLC
state: Alabama
city: Denver
country: United States
facility: Rose Medical Center / Medical Center of Aurora
state: Colorado
city: Washington
country: United States
facility: Medstar Washington Hospital Center
state: District of Columbia
city: Jacksonville
country: United States
facility: St. Vincent's HealthCare
state: Florida
city: Miami Beach
country: United States
facility: Mt Sinai Medical Center
state: Florida
city: Palm Beach Gardens
country: United States
facility: Palm Beach Gardens Medical Center
state: Florida
city: Atlanta
country: United States
facility: Emory University - St. Joseph's Hospital
state: Georgia
city: Indianapolis
country: United States
facility: St. Vincent Medical Group Inc.
state: Indiana
city: Baton Rouge
country: United States
facility: Cardiovascular Research Foundation of Louisiana
state: Louisiana
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
city: Grand Blanc
country: United States
facility: Genesys Regional Medical Center
state: Michigan
city: Tupelo
country: United States
facility: Cardiology Associates Research, LLC
state: Mississippi
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
city: Staten Island
country: United States
facility: Staten Island University Hospital
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University - Vidant Medical Center
state: North Carolina
city: Raleigh
country: United States
facility: Wake Medical Center / Cary Research Group
state: North Carolina
city: Akron
country: United States
facility: Summa Health System
state: Ohio
city: Columbus
country: United States
facility: Riverside Hospital / OhioHealth
state: Ohio
city: Harrisburg
country: United States
facility: UPMC Pinnacle Hospitals
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny-Singer Research Institute
state: Pennsylvania
city: Austin
country: United States
facility: Austin Heart PLLC
state: Texas
city: San Antonio
country: United States
facility: STAR Clinical Trials LLC
state: Texas
city: Richmond
country: United States
facility: Virginia Cardiovascular Specialists
state: Virginia
city: London
country: United Kingdom
facility: St. Bartholomew's Hospital
city: London
country: United Kingdom
facility: Guy's and St. Thomas Hospital
Study officials:
affiliation: Emory St Joseph's Hospital
name: David DeLurgio, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.