The Low Voltage Guided Ablation Trial of Persistent Atrial Fibrillation

Mödling Hospital324 enrolled

Overview

This study evaluates if the exclusion of left atrial low voltage areas / scars by ablation lines in addition to pulmonary vein isolation may improve the outcome in patients with persistent atrial fibrillation in comparison to stand alone pulmonary vein isolation.

This is a prospective, randomized multi center study comparing two catheter ablation strategies (pulmonary vein isolation (PVI) versus PVI plus low voltage areas (LVA) guided for ablation in patients with symptomatic persistent and long standing persistent atrial fibrillation (AF) who were unresponsive to at least one Class I or III antiarrhythmic agents, or it is the patient´s decision to receive ablation as first line therapy. Patients with documented persistent AF who are eligible for participation in the study, and gave a written informed consent, will be randomized between two groups prior to the procedure: PVI and PVI+LVAs guided radiofrequency catheter ablation. All the patients will receive a high density voltage map in sinus rhythm (SR). All the patients will receive circumferential PVI. If LVAs are present, Patients randomized to the PVI+LVA group will get additional linear ablation lines to exclude these areas from normal voltage atrial myocardium. The patients will be followed for 12 months.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

324

Conditions

Persistent Atrial Fibrillation

Interventions

radiofrequency ablationPROCEDURE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Symptomatic patients with persistent AF documented by 12 lead ECGs (Persistent AF is defined as an AF episode which lasts longer than 7 days, Persistent AF which lasted longer than 12 months will be defined as long standing persistent AF.) * Age 18 - 80 years, both genders * Patient is willing to participate in the study (signed written informed consent) * Patient is willing and available to perform all follow ups. Exclusion Criteria: * Atrial fibrillation due to reversible causes * Any contraindication for AF ablation * Contraindications to anticoagulation * CVA/TIA in the past 6 months * Previous left atrial catheter ablation

Locations (6)

Moedling Hospital

Mödling, Lower Austria, Austria

Elisabethinen Hospital

Linz, Upper Austria, Austria

Landesklinikum Wiener Neustadt

Vienna, Austria

Heart Center Dresden

Dresden, Saxony, Germany

Outcomes

Primary Outcomes

recurrence of atrial arrhythmia

recurrence of the first symptomatic or asymptomatic episode of atrial arrhythmia within 12 months after single catheter ablation procedure, with three-month blanking

Time frame: 12 months

Secondary Outcomes

Secondary Efficacy Endpoint

recurrence of the first symptomatic or asymptomatic episode of atrial arrhythmia within 12 months after single catheter ablation procedure, with three-month blanking, on implanted cardiac monitors exclusively

Time frame: 12 months

Secondary Safety Endpoint

occurrence of one or more of the following adverse events within 90 days from ablation: cardiac tamponade/hemopericardium/effusion, pericarditis, stroke/TIA/arterial embolism, pulmonary vein stenosis, atrioesophageal fistula, septicemia, internal bleeding, phrenic nerve palsy, femoral vascular access complication, death

Time frame: 90 days

Data from ClinicalTrials.gov

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