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

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).

Conditions

• Atrial Fibrillation
• Catheter Ablation

Interventions

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

Sponsors & Collaborators

• Hospital Universitario La Paz

  lead OTHER

Principal Investigators

• José L Merino, PhD · Hospital Universitario La Paz, Madrid, España.

• Sergio C Castrejón-Castrejón, PhD · Hospital Universitario La Paz, Madrid, España.

• Carlos Escobar Cervantes, PhD · Hospital Universitario La Paz, Madrid, España.

• Consuelo Froilán Torres, MD · Hospital Universitario La Paz, Madrid, España.

• Andrés Fernández Prieto, MD · Hospital Universitario La Paz, Madrid, España.

• Marcel Martínez Cossiani, MD · Hospital Universitario La Paz, Madrid, España.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-04-25

Primary Completion

2023-04-30

Completion

2023-12-30

Countries

• Spain

Study Locations