Atrial Fibrillation Clinical Trial
Official title:
Ablation of Perimitral Flutter Following Catheter Ablation of Atrial Fibrillation: Impact on Outcomes
This prospective, randomized study aims to compare the impact of ablation of perimitral flutter only versus cardioversion and repeat isolation of pulmonary veins with ablation of additional triggers, on procedure outcome.
Background: In recent years, catheter ablation has been accepted as the treatment-of-choice
for drug-refractory atrial fibrillation (AF). It is centered around isolating pulmonary
veins (PVs) and its success rate in curing AF is very high (56%-85%) (1). However, despite
isolation of this dominant source of triggers, recurrent tachyarrhythmia is the major
complication of this procedure with peri-mitral atrial flutter (PMFL) being the most common
macro-reentrant arrhythmia in context of AF ablation (2). These often drug-refractory
arrhythmias are frequently associated with more severe symptoms than the original AF (3) and
warrant the necessity for redo-ablation.
This study aims to compare the impact of two different redo-ablation strategies on the
procedure outcome; (1) ablation of the perimitral flutter only and (2) cardioversion and
repeat isolation of pulmonary veins (PV) with ablation of additional triggers.
Study method: A total number of 65 AF patients presenting for redo-ablation and PMFL will be
randomized to perimitral flutter ablation only or cardioversion and re-isolation (PVI) plus
ablation of additional triggers. Additional triggers will be identified with the help of
post-ablation drug provocation with isoproterenol. Patients will enter a follow-up period of
12 months after the ablation procedure, when they will be monitored for recurrence of
arrhythmia detected either by in-clinic or remote device interrogation at 1, 3, 6 and 12
month post-procedure.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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