Clinical trial NCT06351553: Effect of the Autonomic Nervous System on the Outcomes of PULSEd Field Ablation to Treat Atrial Fibrillation
Official title: Effect of the Autonomic Nervous System on the Outcomes of PULSEd Field Ablation to Treat Atrial Fibrillation (EASy-PULSE AF)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Pulmonary Vein Isolation
Pulsed Field Ablation
Lead sponsor: Hospital General Universitario de Alicante
Sponsor class: OTHER
First posted: 2024-04-08
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy primary outcome: Alteration of autonomic function parameters
timeFrame: Two years
Secondary outcomes:
measure: Efficacy secondary outcome: Alteration of autonomic function parameters
timeFrame: Two years
measure: Efficacy secondary outcome: Alteration of autonomic function parameters
timeFrame: Two years
measure: Efficacy secondary outcome: Alteration of autonomic function parameters
timeFrame: Two years
measure: Efficacy secondary outcome: Procedure duration.
timeFrame: Two years
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Laura García Cano
Study officials:
References: