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

NANot yet recruitingINTERVENTIONAL
Enrollment

156

Participants

Timeline

Start Date

June 30, 2024

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2026

Conditions
Atrial Fibrillation
Interventions
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.

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.

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."

Trial Locations (1)

03010

Laura García Cano, Alicante

All Listed Sponsors
lead

Hospital General Universitario de Alicante

OTHER

NCT06351553 - Effect of the Autonomic Nervous System on the Outcomes of PULSEd Field Ablation to Treat Atrial Fibrillation | Biotech Hunter | Biotech Hunter