A prospective multi-arm parallel group randomized clinical trial to compare the efficacy of three ablation strategies in patients with persistent atrial fibrillation using using a lattice-tip catheter that can switch between RFA and PFA energy. The incremental benefit of posterior wall isolation (PWI) and mitral isthmus ablation may contribute to greater freedom from atrial fibrillation at twelve months.
This is a prospective randomized clinical trial. Patients will undergo catheter ablation for persistent AF using a lattice-tip catheter that can switch between RFA and PFA energy. Enrolled patients will be randomized to one of three ablation strategies: 1. Pulmonary vein isolation using PFA energy 2. Pulmonary vein isolation and posterior wall isolation using PFA energy 3. Pulmonary vein isolation and posterior wall isolation (PFA) and mitral isthmus ablation using RFA or PFA energy. Patients will receive an implantable loop recorder prior to, during or post index ablation procedure for continuous monitoring for clinical recurrence of AF/AT/AFL
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
This is a prospective randomized clinical trial. Patients will undergo catheter ablation for persistent AF using a lattice-tip catheter that can switch between RFA and PFA energy. Enrolled patients will be randomized to one of three ablation strategies:
North Shore University Hospital
Manhasset, New York, United States
RECRUITINGLong Island Jewish Medical Center
New Hyde Park, New York, United States
RECRUITINGKristie Coleman
New York, New York, United States
RECRUITINGPercent of subjects free from primary effectiveness failure
The primary effectiveness endpoint is freedom from documented recurrence of AF, atrial tachycardia (AT), or atrial flutter (AFL) lasting \>2 minutes based on electrocardiographic data through 12-month follow-up and excluding a 60-day blanking period.
Time frame: 12 Months
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