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

Atrial Fibrillation Clinical Trial

— POWER-FAST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04153747
• Other study ID #: 5064
• Status: Completed
• Phase: N/A
• Start date: April 25, 2019
• Est. completion date: December 30, 2023

Study information

• Verified date: January 2024
• Source: Hospital Universitario La Paz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: December 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Catheter Ablation

Intervention

Other:
• High-power and short-duration radiofrequency ablatio (70 W / 9-10 s)
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
Pulmonary veins electrical isolation: low-power ablation.
• Esophageal endoscopy
Esophageal endoscopy to detect postablation esophageal thermal lesions.

Diagnostic Test:
• Daily 30-seconds ECG
Transtelephonic daily 30-seconds single lead electrocardiogram

Locations

Country	Name	City	State
Spain	University Hospital La Paz, Department of Cardiology	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario La Paz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	Total radiofrequency time	Total radiofrequency time required for complete pulmonary veins isolation (included acute intraprocedural reconnections and dormant conduction).	during ablation procedure