Clinical trial NCT02732626: The Low Voltage Guided Ablation Trial of Persistent Atrial Fibrillation
Official title: The Low Voltage Guided Ablation Trial of Persistent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Persistent Atrial Fibrillation
Lead sponsor: Mödling Hospital
Sponsor class: OTHER
Collaborators: name: Technische Universität Dresden
name: Medical University of Vienna
name: Medical University of Lublin
name: Elisabethinen Hospital
First posted: 2016-04-08
Enrollment: 324
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: recurrence of atrial arrhythmia
timeFrame: 12 months
Secondary outcomes:
measure: Secondary Efficacy Endpoint
timeFrame: 12 months
measure: Secondary Safety Endpoint
timeFrame: 90 days
Other outcomes:
Locations:
city: Mödling
country: Austria
facility: Moedling Hospital
state: Lower Austria
city: Linz
country: Austria
facility: Elisabethinen Hospital
state: Upper Austria
city: Vienna
country: Austria
facility: Landesklinikum Wiener Neustadt
city: Dresden
country: Germany
facility: Heart Center Dresden
state: Sachsen
city: Lübeck
country: Germany
facility: Sana Kliniken Lübeck
city: Lublin
country: Poland
facility: Medical University of Lublin
Study officials:
affiliation: Heart Center Dresden
name: Christopher Piorkowski, MD
role: PRINCIPAL_INVESTIGATOR
References: