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NCT Number: NCT04153747

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

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).

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Catheter Ablation Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital La Paz, Department of Cardiology

Madrid, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other

Pulmonary veins electrical isolation: 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.

Esophageal endoscopy

Other

Esophageal endoscopy to detect postablation esophageal thermal lesions.

Daily 30-seconds ECG

Diagnostic Test

Transtelephonic daily 30-seconds single lead electrocardiogram

Other names: Transtelephonic daily 30-seconds single lead electrocardiogram

Primary outcomes

  1. Safety: incidence of esophageal thermal lesions

    Time frame: 24 hours after ablation (permissible up to 72 hours after ablation)

    Incidence of thermal esophageal lesions evaluated by endoscopy

  2. Efficacy: recurrence of atrial arrhythmias

    Time frame: 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).

  3. Total radiofrequency time

    Time frame: during ablation procedure

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

Sponsors and collaborators

Lead sponsor

Hospital Universitario La Paz

Other

Registry information

Official study title

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

Acronym: POWER-FAST

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Nov 6, 2019
Registry last updated
Jan 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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