Clinical trial NCT04153747: High Radiofrequency Power for Faster and Safer Pulmonary Vein Ablation Trial (POWER FAST III)
Official title: High-power Short-duration Radiofrequency Application for Faster and Safer Pulmonary Vein Ablation Trial (POWER FAST III Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Catheter Ablation
Lead sponsor: Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2019-11-06
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety: incidence of esophageal thermal lesions
timeFrame: 24 hours after ablation (permissible up to 72 hours after ablation)
measure: Efficacy: recurrence of atrial arrhythmias
timeFrame: 1 year
measure: Total radiofrequency time
timeFrame: during ablation procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: University Hospital La Paz, Department of Cardiology
Study officials:
affiliation: Hospital Universitario La Paz, Madrid, España.
name: José L Merino, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario La Paz, Madrid, España.
name: Sergio C Castrejón-Castrejón, PhD
role: STUDY_CHAIR
affiliation: Hospital Universitario La Paz, Madrid, España.
name: Carlos Escobar Cervantes, PhD
role: STUDY_CHAIR
affiliation: Hospital Universitario La Paz, Madrid, España.
name: Consuelo Froilán Torres, MD
role: STUDY_CHAIR
affiliation: Hospital Universitario La Paz, Madrid, España.
name: Andrés Fernández Prieto, MD
role: STUDY_CHAIR
affiliation: Hospital Universitario La Paz, Madrid, España.
name: Marcel Martínez Cossiani, MD
role: STUDY_CHAIR
References: