Symptomatic Paroxysmal Atrial Fibrillation
Conditions
Keywords
MRI, left-sided atrial catheter ablation, paroxysmal atrial fibrillation, cryoballoon technique, mesh ablator catheter, stroke, silent stroke, major complications
Brief summary
The purpose of this prospective randomized single-center trial is to compare efficiency and safety of two pulmonary vein ablation systems in patients with symptomatic paroxysmal atrial fibrillation using the Arctic Front® versus the HD Mesh Ablator® catheter.
Detailed description
Primary objective: • Efficacy of pulmonary vein isolation defined by achieving an exit block for all pulmonary veins per patient. Secondary objectives: * Detecting (silent) cerebral thromboembolism using neuro(psychological) tests and brain MRI prior and within 2 days after PV ablation. * Detecting (silent) cerebral thromboembolism using neuro(psychological) tests and brain MRI within 6 months after PV ablation. * Determination of spontaneous recurrence rate of atrial fibrillation using a subcutaneously implanted loop recorder (Reveal XT®). * Characterization of non-neurological major complications (death, atrial-esophageal fistula, pulmonary vein stenosis, pericardial tamponade) * Rate of iatrogenic interatrial septal defects after transseptal puncture for PV ablation.
Interventions
PROCEDUREArctic Front® catheter vs. HD Mesh Ablator® catheter
Pulmonary vein ablation in patients with symptomatic paroxysmal atrial fibrillation using the Arctic Front® catheter versus the HD Mesh Ablator® catheter
Sponsors
German Federal Ministry of Education and Research
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients with ECG-documented symptomatic paroxysmal atrial fibrillation and at least one ineffective antiarrhythmic drug treatment
Exclusion criteria
* Previous ablation procedure for atrial fibrillation or cardiac surgery within 3 months * Left atrial diameter \> 50mm or ejection fraction \< 35% * Instable coronary artery disease or clinically relevant cardiac valve insufficiency * Hyperthyroidism, pregnancy or lactation; coumadin or heparin intolerance * Concomitant disease with expected lifespan \< 2 years * Contraindications for MRI or acute cerebral infarction detected by brain MRI immediately (\< 24 hours) before catheter ablation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of pulmonary vein isolation defined by achieving an exit block for all pulmonary veins per patient | During ablation procedure |
Secondary
| Measure | Time frame |
|---|---|
| Detecting (silent) cerebral thromboembolism using neuro(psychological) tests and brain MRI | within 2 days after catheter ablation |
| Determination of spontaneous recurrence rate of atrial fibrillation using a subcutaneously implanted loop recorder (Reveal XT®) | 1 year after catheter ablation |
| Characterization of non-neurologic major complications (death, atrial-esophageal fistula, pulmonary vein stenosis, pericardial tamponade) | within 1 month after catheter ablation |
| Rate of iatrogenic interatrial septal defects after transseptal puncture for left-sided atrial catheter ablation | 1 year after catheter ablation |
Countries
Germany
Outcome results
None listed