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

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

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).

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 304
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain
    • University Hospital La Paz, Department of Cardiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional ablation; 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.	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; Other Names: Transtelephonic daily 30-seconds single lead electrocardiogram
Experimental: High-power and short-duration ablation; 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.	Other: Esophageal endoscopy; Esophageal endoscopy to detect postablation esophageal thermal lesions.; Diagnostic test: Daily 30-seconds ECG; Transtelephonic daily 30-seconds single lead electrocardiogram; Other Names: Transtelephonic daily 30-seconds single lead electrocardiogram; Other: High-power and short-duration radiofrequency ablatio (70 W / 9-10 s); Pulmonary veins electrical isolation: high-power and short-duration ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety: incidence of esophageal thermal lesions	Incidence of thermal esophageal lesions evaluated by endoscopy	24 hours after ablation (permissible up to 72 hours after ablation)
Total radiofrequency time	Total radiofrequency time required for complete pulmonary veins isolation (included acute intraprocedural reconnections and dormant conduction).	during ablation procedure
Efficacy: recurrence of atrial arrhythmias	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).	1 year

Collaborators and Investigators

• Sponsor: Hospital Universitario La Paz
• Investigators: Principal Investigator: José L Merino, PhD, Hospital Universitario La Paz, Madrid, España.; Study Chair: Sergio C Castrejón-Castrejón, PhD, Hospital Universitario La Paz, Madrid, España.; Study Chair: Carlos Escobar Cervantes, PhD, Hospital Universitario La Paz, Madrid, España.; Study Chair: Consuelo Froilán Torres, MD, Hospital Universitario La Paz, Madrid, España.; Study Chair: Andrés Fernández Prieto, MD, Hospital Universitario La Paz, Madrid, España.; Study Chair: Marcel Martínez Cossiani, MD, Hospital Universitario La Paz, Madrid, España.

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2019
• Primary Completion (Actual): April 30, 2023
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: November 2, 2019
• First Submitted That Met QC Criteria: November 4, 2019
• First Posted (Actual): November 6, 2019

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 5064

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No