Persistent Atrial Fibrillation
Conditions
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.
Interventions
PROCEDUREradiofrequency ablation
Sponsors
Technische Universität Dresden
Medical University of Vienna
Medical University of Lublin
Elisabethinen Hospital
Mödling Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Austria, Germany, Poland
Outcome results
None listed