156
Participants
Start Date
June 30, 2024
Primary Completion Date
June 30, 2026
Study Completion Date
June 30, 2026
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."
Laura García Cano, Alicante
Hospital General Universitario de Alicante
OTHER