Effect of the Autonomic Nervous System on the Outcomes of PULSEd Field Ablation to Treat Atrial Fibrillation - Trial NCT06351553

Timeline & Enrollment

Primary Outcome

Efficacy primary outcome: Alteration of autonomic function parameters

Summary

Pulmonary vein (PV) isolation is considered the therapeutic strategy of choice to maintain
 sinus rhythm (SR) in symptomatic patients with atrial fibrillation (AF). The most commonly
 used energy modality is radiofrequency (RF). However, this type of energy presents notable
 challenges, such as its lack of selectivity for myocardial tissue, which increases the risk
 of serious complications such as atrioesophageal fistula, PV stenosis, and vagus nerve
 injuries. In this context, PV isolation using pulsed field ablation (PFA) emerges as a
 promising alternative due to its greater myocardial selectivity. However, this selectivity
 presents additional challenges. Preliminary studies indicate that PFA may not damage the
 autonomic nervous system (ANS) involved in the initiation and maintenance of AF in certain
 patients, although stronger evidence is needed to support this claim.
 
 The investigators propose to carry out a single-center clinical trial, although with the
 possibility in the future of including other centers. Patients will be randomized to three
 research groups: PV isolation with RF, PV isolation with PFA, and PV isolation combining PFA
 and RF (using RF on the anterior wall and PFA on the posterior wall). This assignment will be
 open to the operator who performs the procedure, but blind for the researcher responsible for
 monitoring and for the data analyst. The objective is to compare the impact of different
 energy sources during PV isolation on the ability to produce a permanent alteration in the
 ANS. The hypothesis is that combined PF isolation will be capable of producing a permanent
 alteration of autonomic function parameters superior to ablation using exclusive PFA.

ICD-10 Classifications