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

Atrial Fibrillation Clinical Trial

— EASy-PULSE AF  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06351553
• Other study ID #: 2023-169
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: June 2026

Study information

• Verified date: April 2024
• Source: Hospital General Universitario de Alicante
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 156
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Pulmonary vein isolation exclusively with radiofrequency
The QDOT (Biosense Webster, Inc.) or TactiFlex (Abbott S.E.) catheters will be used. The ablation will be controlled by temperature, with a limit of 42ºC and a power target of 30-40W. A high-power strategy (90 W/4 seconds) can be used on the posterior wall when the QDOT catheter is used.
• Pulmonary vein isolation exclusively with pulsed field ablation
The Sphere-9 catheter will be used (with biphasic and unipolar wave), with a duration per application of 5 seconds and a separation between lesions of 5-6mm. The target temperature increase will be at least 1.5ºC above the patient's basal temperature to mark the ablation as effective.
• Combined pulmonary vein isolation
The Sphere-9 catheter will be used for both radiofrequency and pulsed field ablation. When using radiofrequency, the ablation will be temperature controlled, with a target temperature of 73ºC. The duration per application will be 5 seconds. Catheter irrigation during ablation will be 30ml/min, with a maximum current intensity of 3700mA, and a maximum current density of 13.6mA/mm2. The separation between lesions will be 7-8mm. Regarding pulsed field ablation, the characteristics will be those indicated in "Pulmonary vein isolation exclusively with pulsed field ablation" group.

Locations

Country	Name	City	State
Spain	Laura García Cano	Alicante

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General Universitario de Alicante

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy primary outcome: Alteration of autonomic function parameters	Determine if combined pulmonary vein isolation (anterior wall ablation with radiofrequency and posterior wall ablation with pulsed field ablation) will be capable of producing a permanent alteration of autonomic function parameters (average heart rate) greater than exclusive pulsed field ablation.	Two years
Secondary	Efficacy secondary outcome: Alteration of autonomic function parameters	Determine if combined pulmonary vein isolation (anterior wall ablation with radiofrequency and posterior wall ablation with pulsed field ablation) will be capable of producing a permanent alteration of autonomic function parameters (attenuation of heart rate variability) greater than exclusive pulsed field ablation.	Two years
Secondary	Efficacy secondary outcome: Alteration of autonomic function parameters	Determine if combined pulmonary vein isolation (anterior wall ablation with radiofrequency and posterior wall ablation with pulsed field ablation) is at least as effective as exclusive radiofrequency pulmonary vein isolation in its ability to produce a permanent alteration of autonomic function parameters (average heart rate).	Two years
Secondary	Efficacy secondary outcome: Alteration of autonomic function parameters	Determine if combined pulmonary vein isolation (anterior wall ablation with radiofrequency and posterior wall ablation with pulsed field ablation) is at least as effective as exclusive radiofrequency pulmonary vein isolation in its ability to produce a permanent alteration of autonomic function parameters (attenuation of heart rate variability).	Two years
Secondary	Efficacy secondary outcome: Procedure duration.	Determine if combined pulmonary vein isolation or exclusive pulmonary vein isolation with pulsed field ablation will shorten procedure times compared to exclusive radiofrequency pulmonary vein isolation.	Two years