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

NCT ID: NCT06351553

Last Updated: 2024-04-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-30
• Study Completion Date: 2026-06-30

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.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Pulmonary vein isolation exclusively with radiofrequency

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

Group Type: ACTIVE_COMPARATOR

Pulmonary vein isolation exclusively with radiofrequency

Intervention Type: PROCEDURE

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

Group Type: EXPERIMENTAL

Pulmonary vein isolation exclusively with pulsed field ablation

Intervention Type: PROCEDURE

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

Group Type: EXPERIMENTAL

Combined pulmonary vein isolation

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital General Universitario de Alicante

OTHER

Sponsor Role: lead

Responsible Party

Jose Luis Ibañez Criado

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Laura García Cano

Alicante, , Spain

Countries

Spain

Other Identifiers

2023-169

Identifier Type: -

Identifier Source: org_study_id