Effect of the Autonomic Nervous System on the Outcomes of PULSEd Field Ablation to Treat Atrial Fibrillation (EASy-PULSE AF)

Hospital General Universitario de Alicante

Status: Not yet enrolling

Conditions: Atrial Fibrillation

Treatments: Procedure: Pulmonary vein isolation exclusively with radiofrequency; Procedure: Pulmonary vein isolation exclusively with pulsed field ablation; Procedure: Combined pulmonary vein isolation

Study type: Interventional

Funder types: Other

Identifiers

NCT06351553

2023-169

Details and patient eligibility

About

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.

Enrollment: 156 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with a diagnosis of paroxysmal atrial fibrillation, referred to our center for pulmonary vein isolation, who are willing and able to sign the informed consent.

Exclusion criteria

• Patients with permanent atrial fibrillation.
• Patients with previous pulmonary vein isolation procedure.
• Patients with pacemakers, or with a diagnosis of atrioventricular block or sinus dysfunction.
• Patients who show their refusal to participate in the registry, or are unable to understand the informed consent.
• Patients under 18 years of age.
• Pregnant.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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156 participants in 3 patient groups

Pulmonary vein isolation exclusively with radiofrequency

Active Comparator group

Description:

The ablation of the anterior and posterior wall will be performed with radiofrequency.

Treatment:

Procedure: Pulmonary vein isolation exclusively with radiofrequency

Pulmonary vein isolation exclusively with pulsed field ablation

Experimental group

Description:

The ablation of the anterior and posterior wall will be performed with pulsed field ablation.

Treatment:

Procedure: Pulmonary vein isolation exclusively with pulsed field ablation

Combined pulmonary vein isolation

Experimental group

Description:

The ablation of the anterior wall will be performed with radiofrequency, and the posterior wall with pulsed field ablation.

Treatment:

Procedure: Combined pulmonary vein isolation