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

AtriCure

Status: Completed

Conditions: Persistent Atrial Fibrillation

Treatments: 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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01984346

IDE Number G130084 (Other Identifier)

VAL-1200

Details and patient eligibility

About

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).

Full 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.

Enrollment: 170 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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170 participants in 2 patient groups

Convergent Procedure

Experimental group

Description:

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

Treatment:

Device: Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering

Device: AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax

Standalone Endocardial Catheter Ablation

Active Comparator group

Description:

Procedure/Surgery: Endocardial Catheter Ablation Treatment

Treatment:

Device: Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering