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

Not Applicable

Completed

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

• Registration Number: NCT04153747
• Lead Sponsor: Hospital Universitario La Paz

Brief 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.

Study Timeline

• Study Start: 2019-04-25
• Study First Submitted: 2019-11-02
• Study First Submitted QC: 2019-11-04
• Study First Posted: 2019-11-06
• Primary Completion: 2023-04-30
• Study Completion: 2023-12-30
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-08
• Last Update Posted: 2024-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 304

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional ablation	Daily 30-seconds ECG	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.
Conventional ablation	Low-power (25-40 W) radiofrequency ablation guided by lesion size index (LSI) and ablation index (AI) values	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.
Conventional ablation	Esophageal endoscopy	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.
High-power and short-duration ablation	High-power and short-duration radiofrequency ablatio (70 W / 9-10 s)	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.
High-power and short-duration ablation	Daily 30-seconds ECG	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.
High-power and short-duration ablation	Esophageal endoscopy	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.

Primary Outcome Measures

Name	Time	Method
Total radiofrequency time	during ablation procedure	Total radiofrequency time required for complete pulmonary veins isolation (included acute intraprocedural reconnections and dormant conduction).
Safety: incidence of esophageal thermal lesions	24 hours after ablation (permissible up to 72 hours after ablation)	Incidence of thermal esophageal lesions evaluated by endoscopy
Efficacy: recurrence of atrial arrhythmias	1 year	Recurrences of any atrial arrhythmias \>30 seconds during 1-year follow-up evaluated by daily transtelephonic ECG transmissions (at least 1 ECG/day and additional transmissions whenever the patient perceives arrhythmia-related symptoms).

Trial Locations

Locations (1)

University Hospital La Paz, Department of Cardiology; 🇪🇸 Madrid, Spain