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

NCT04153747 | Completed DMC

• 1 other identifier: 5064
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

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).

Conditions

Atrial Fibrillation; Catheter Ablation

Outcome Measures

Primary Outcomes (3)

• 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)

• 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

• Total radiofrequency time

  Total radiofrequency time required for complete pulmonary veins isolation (included acute intraprocedural reconnections and dormant conduction).

  during ablation procedure

Study Arms (2)

Conventional ablation

ACTIVE COMPARATOR

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; Other: Esophageal endoscopy; Diagnostic Test: Daily 30-seconds ECG

High-power and short-duration ablation

EXPERIMENTAL

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: High-power and short-duration radiofrequency ablatio (70 W / 9-10 s); Other: Esophageal endoscopy; Diagnostic Test: Daily 30-seconds ECG

Interventions

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

Pulmonary veins electrical isolation: high-power and short-duration ablation

High-power and short-duration ablation

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

Pulmonary veins electrical isolation: low-power ablation.

Conventional ablation

Esophageal endoscopy OTHER

Esophageal endoscopy to detect postablation esophageal thermal lesions.

Conventional ablation; High-power and short-duration ablation

Daily 30-seconds ECG DIAGNOSTIC_TEST

Transtelephonic daily 30-seconds single lead electrocardiogram

Also known as: Transtelephonic daily 30-seconds single lead electrocardiogram

Conventional ablation; High-power and short-duration ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario La Paz: lead

Study Sites (1)

University Hospital La Paz, Department of Cardiology

Madrid, Spain

Location

Related Publications (1)

• Castrejon-Castrejon S, Martinez Cossiani M, Basterra Sola N, Romero Roldan JD, Ibanez Criado JL, Osca J, Roca-Luque I, Moya A, Quesada A, Hidalgo Olivares VM, Perez Castellano N, Fernandez-Gomez JM, Macias-Ruiz R, Villanueva BB, Gonzalo Bada N, Froilan Torres C, Sanz Verdejo B, Sanchez Somonte P, Escobar Cervantes C, Moreno R, Merino JL; POWER FAST III Trial Investigators. High-Power Short-Duration Radiofrequency Application for Faster and Safer Pulmonary Vein Isolation: The POWER-FAST III Trial. JACC Clin Electrophysiol. 2025 Feb;11(2):350-361. doi: 10.1016/j.jacep.2024.10.009. Epub 2024 Dec 18.

  PMID: 39708035 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Laser Speckle Contrast Imaging; Electrocardiography

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Electrodiagnosis

Study Officials

• José L Merino, PhD

  Hospital Universitario La Paz, Madrid, España.

  PRINCIPAL INVESTIGATOR

• 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 CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Electrophysiologist, Principal investigator (together with Dr. José Luis Merino)

Study Record Dates

• First Submitted: November 2, 2019
• First Posted: November 6, 2019
• Study Start: April 25, 2019
• Primary Completion: April 30, 2023
• Study Completion: December 30, 2023
• Last Updated: January 10, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)