NCT04153747

High Radiofrequency Power for Faster and Safer Pulmonary Vein Ablation Trial (POWER FAST III)

High-power Short-duration Radiofrequency Application for Faster and Safer Pulmonary Vein Ablation Trial (POWER FAST III Trial)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 304 (actual)
• Sponsor: Hospital Universitario La Paz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Multicenter 1:1 randomized study. Two atrial fibrillation ablation strategies are compared: 1) conventional ablation using point-by-point radiofrequency applications with power 40 W guided by LSI \> 6 or AI \> 500 on the anterior aspect of pulmonary veins and power 25 W guided by LSI \>5 or AI \>350 on the posterior wall near the esophagus; 2) point-by-point RF applications with power set at 70 W and duration 9-10 s. The main objective of the trial is the incidence of esophageal lesions evaluated with systematic endoscopy and clinical efficacy evaluated with daily ECG transtelephonic transmissions during 1-year follow-up. Secondary objectives include total RF time and parameters of acute PV isolation efficacy (first-pass isolation, acute reconnections and dormant conduction).

Detailed description

Multicenter 1:1 randomized study: Hospital Universitario La Paz, Madrid; Hospital Clínico Universitario San Carlos, Madrid; Hospital Clínico y Provincial de Barcelona, Barcelona; Complejo Hospitalario de Navarra, Pamplona; Hospital Clínico Universitario de Valladolid; Hospital Clínico Universitario de Albacete; Hospital Clínico Universitario de Alicante; Hospital Universitario Virgen de las Nieves, Granada; Hospital La Fe, Valencia; Hospital Clínico de Valencia; Hospital Universitario Juan Ramón Jiménez, Huelva; Hospital de la Ribera, Alzira, Valencia. España. Spain. Two atrial fibrillation ablation strategies are compared: 1) conventional ablation using point-by-point radiofrequency applications with power 40 W guided by LSI \> 6 or AI \> 500 on the anterior aspect of pulmonary veins and power 25-40 W guided by LSI \>5 or AI \>350 on the posterior wall near the esophagus; 2) point-by-point RF applications with power set at 70 W and duration 9-10 s. The main objective of the trial is the incidence of esophageal lesions evaluated with systematic endoscopy and clinical efficacy evaluated with daily ECG transtelephonic transmissions during 1-year follow-up. Secondary objectives include total RF time and parameters of acute PV isolation efficacy (first-pass isolation, acute reconnections and dormant conduction). Subestudy: asymptomatic cerebral lesions detected by 1,5 T MRI \<72 h after ablation. Not all centers participate in the subestydy. However, if the center participates, all patients in both ablation groups will be included in the subestudy.

Conditions

• Atrial Fibrillation
• Catheter Ablation

Interventions

Type	Name	Description
OTHER	High-power and short-duration radiofrequency ablatio (70 W / 9-10 s)	Pulmonary veins electrical isolation: high-power and short-duration ablation
OTHER	Low-power (25-40 W) radiofrequency ablation guided by lesion size index (LSI) and ablation index (AI) values	Pulmonary veins electrical isolation: low-power ablation.
OTHER	Esophageal endoscopy	Esophageal endoscopy to detect postablation esophageal thermal lesions.
DIAGNOSTIC_TEST	Daily 30-seconds ECG	Transtelephonic daily 30-seconds single lead electrocardiogram

Timeline

• Start date: 2019-04-25
• Primary completion: 2023-04-30
• Completion: 2023-12-30
• First posted: 2019-11-06
• Last updated: 2024-01-10

Locations

1 site across 1 country: Spain