The Low Voltage Guided Ablation Trial of Persistent Atrial Fibrillation
- Conditions
- Persistent Atrial Fibrillation
- Interventions
- Procedure: radiofrequency ablation
- Registration Number
- NCT02732626
- Lead Sponsor
- Mödling Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 324
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description pulmonary vein isolation alone radiofrequency ablation patients randomized to this group receive stand alone pulmonary vein isolation regardless to their left atrial voltage map pulmonary vein isolation + low voltage area guided ablation radiofrequency ablation patients randomized to this group receive pulmonary vein isolation + low voltage area guided linear substrate modification in the case if there are any
- Primary Outcome Measures
Name Time Method recurrence of atrial arrhythmia 12 months recurrence of the first symptomatic or asymptomatic episode of atrial arrhythmia within 12 months after single catheter ablation procedure, with three-month blanking
- Secondary Outcome Measures
Name Time Method Secondary Efficacy Endpoint 12 months 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
Secondary Safety Endpoint 90 days 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
Trial Locations
- Locations (6)
Elisabethinen Hospital
🇦🇹Linz, Upper Austria, Austria
Moedling Hospital
🇦🇹Mödling, Lower Austria, Austria
Landesklinikum Wiener Neustadt
🇦🇹Vienna, Austria
Heart Center Dresden
🇩🇪Dresden, Sachsen, Germany
Medical University of Lublin
🇵🇱Lublin, Poland
Sana Kliniken Lübeck
🇩🇪Lübeck, Germany