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

Madrid Health Service

Status: Completed

Conditions: Atrial Fibrillation; Catheter Ablation

Treatments: Other: Esophageal endoscopy; Other: Low-power (25-40 W) radiofrequency ablation guided by lesion size index (LSI) and ablation index (AI) values; Diagnostic Test: Daily 30-seconds ECG; Other: High-power and short-duration radiofrequency ablatio (70 W / 9-10 s)

Study type: Interventional

Funder types: Other

Identifiers

NCT04153747

5064

Details and patient eligibility

About

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).

Full 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.

Enrollment: 304 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Paroxysmal or persistent atrial fibrillation.
• Currently accepted class I or II indication for ablation according to practice guidelines: symptomatic arrhythmia, failure of at least 1 antiarrhythmic drug or patient's manifest preference of ablation instead of drugs.
• Age > 18 years.
• Acceptance of informed consent.

Exclusion criteria

• Previous pulmonary veins ablation of any type.
• Permanent atrial fibrillation or long-standing persistent AF (>1 year).
• Heart surgery <3 months before ablation.
• Coronary revascularization of any type <3 months before ablation.
• Myocardial infarction or acute coronary syndrome < 3 months before ablation.
• Stroke or transient cerebral ischaemic attack < 3 months before ablation.
• Persistent left atrial thrombus.
• Contraindication for anticoagulation.
• Absolute indication of double antiplatelet drugs.
• Complex congenital heart disease, corrected or not.
• Any clinical situation absolutely precluding an interventional procedure.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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304 participants in 2 patient groups

Conventional ablation

Active Comparator group

Description:

Point-by-point catheter-based pulmonary veins isolation using convencional radiofrequency parameters. * Anterior aspect of pulmonary veins: 40 W, temperature limit 45 ºC, irrigation 17-30 ml/min; objective LSI\>=6 or Ablation index \>=500. * Posterior aspect of pulmonary veins: 20-40 W, temperature limit 45 ºC, irrigation 17-3 ml/min; objective LSI\>=5 or Ablation index \>=350.

Treatment:

Other: Esophageal endoscopy

Diagnostic Test: Daily 30-seconds ECG

Other: Low-power (25-40 W) radiofrequency ablation guided by lesion size index (LSI) and ablation index (AI) values

High-power and short-duration ablation

Experimental group

Description:

Point-by-point catheter-based pulmonary veins isolation using high-power and short duration radiofrequency: 70 W, duration per application 9-10 s (initial ramp 2-3 s according to the technical characterictics of radiofrequency sources), temperature limit 45 ºC, irrigation 17 ml/min, contac-force \> 5 g.

Treatment:

Other: High-power and short-duration radiofrequency ablatio (70 W / 9-10 s)

Other: Esophageal endoscopy

Diagnostic Test: Daily 30-seconds ECG