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

NCT06351553 | Not Yet Recruiting DMC

• 1 other identifier: 2023-169
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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

Keywords

Atrial Fibrillation; Pulmonary Vein Isolation; Pulsed Field Ablation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Efficacy secondary outcome: Alteration of autonomic function parameters

  Two years

• Efficacy secondary outcome: Alteration of autonomic function parameters

  Two years

• Efficacy secondary outcome: Alteration of autonomic function parameters

  Two years

• Efficacy secondary outcome: Procedure duration.

  Two years

Study Arms (3)

Pulmonary vein isolation exclusively with radiofrequency

ACTIVE COMPARATOR

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

Procedure: Pulmonary vein isolation exclusively with radiofrequency

Pulmonary vein isolation exclusively with pulsed field ablation

EXPERIMENTAL

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

Procedure: Pulmonary vein isolation exclusively with pulsed field ablation

Combined pulmonary vein isolation

EXPERIMENTAL

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

Procedure: Combined pulmonary vein isolation

Interventions

Pulmonary vein isolation exclusively with radiofrequency 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 radiofrequency

Pulmonary vein isolation exclusively with pulsed field ablation 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.

Pulmonary vein isolation exclusively with pulsed field ablation

Combined pulmonary vein isolation 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.

Combined pulmonary vein isolation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital General Universitario de Alicante: lead

Study Sites (1)

Laura García Cano

Alicante, 03010, Spain

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: April 8, 2024
• Study Start: June 1, 2024
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: April 8, 2024

Record last verified: 2024-04

Locations

ES (1)