Mesh Ablator Versus Cryoballoon Pulmonary Vein Ablation of Symptomatic Paroxysmal Atrial Fibrillation (MACPAF)
Status and phase
Terminated
Phase 4
Conditions
Symptomatic Paroxysmal Atrial Fibrillation
Treatments
Procedure: Arctic Front® catheter vs. HD Mesh Ablator® catheter
Details and patient eligibility
About
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.
Full 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.
Enrollment
108 estimated patients
Sex
All
Ages
18 to 75 years old
Volunteers
No Healthy Volunteers
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.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Single Blind
108 participants in 2 patient groups
Arctic Front® catheter
Active Comparator group
Treatment:
Procedure: Arctic Front® catheter vs. HD Mesh Ablator® catheter
HD Mesh Ablator® catheter
Active Comparator group
Treatment:
Procedure: Arctic Front® catheter vs. HD Mesh Ablator® catheter
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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