Paroxysmal Atrial Fibrillation Clinical Trial
Official title:
Arrhythmia Inducibility Versus Elimination of Dormant PV Conduction as a Procedural Endpoint of Catheter Ablation for Paroxysmal Atrial Fibrillation: a Prospective Randomized Trial
This study investigates impact of adenosine versus AF inducibility and subsequent termination on the acute and long-term outcome of paroxysmal AF ablation.
Despite intensive efforts to increase single procedure success rates of pulmonary vein
isolation (PVI) for paroxysmal atrial fibrillation (AF), an arrhythmia-free surveillance has
not raised beyond 80%. This prospective, randomized study investigates the efficacy of two
different procedural endpoints in terms of single-procedure arrhythmia-free outcome.
A total number of 152 patients undergoing de-novo catheter ablation for paroxysmal AF will
be randomized to two different treatment arms. In group-A patients, PVI will be performed
with the patient either in spontaneous or induced AF. If AF will not terminate with PVI,
ablation will be continued by targeting extra-PV AF sources with the desired endpoint of
termination to sinus rhythm (SR). The ablation procedure in group-B patients consists of PVI
exclusively, regardless to the underlying rhythm. In this group, all isolated PVs will be
challenged to adenosine administration in the attempt to reveal and ablate dormant
conduction. The primary endpoint is arrhythmia-free survival during a follow-up of 1 year.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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