High Radiofrequency Power for Faster and Safer Pulmonary Veins Isolation - a Pilot Observational Study. (POWER_FAST)

Feasibility, Safety and Mid-term Efficacy of Pulmonary Vein Isolation by High-power Short-duration Radiofrequency Application: the POWER FAST Pilot Study.

The POWER FAST I pilot study is a unicentric, observational, non-randomized controlled clinical study. In the control group pulmonary veins isolation was performded in consecutive patients with irrigated radiofrequency cateters without contact force-sensing capabilities and using conventional low-power and long-duration radiofrequency parameters (20-30 W, 30-60 s) under continuous intracardiac-echo image and esophageal temperature monitoring. The study group consist of consecutive patients distributed in three succesive subgroups. In the study group radiofrequency ablation was performed using a point-by-point technique with contact-force catheters with different high-power and short-duration parameters:

• Subgroup 50W: power 50 W, application duration ≤ 30 s, target lesion index: LSI ≥ 5 or Ablation Index ≥ 350 (posterior wall) or ≥400 (anterior wall).
• Subgroup 60W: power 60 W, application duration 7-10 s, contact force ≥5 g.
• Subgroup 70W: power 70 W, application duration 9 s, contact force ≥5 g.

The safety endpoint was evaluated with systematic esophageal endoscopy performed <72 h after the index procedure. The efficacy endpoint was evaluated:

• during the ablation procedure: acute procedural efficacy, firts-pass isolation of ipsilateral pulmonary veins, total radiofrequency and procedural time, acute reconnections and dormant conduction,
• during the follow-up: any atrial tachycardias documented and longer than 30 s were considered recurrences.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Cardiac Arrhythmia; Atrial Tachycardia; Esophagus Injury
• Intervention / Treatment: Other: Conventional LSI/AI-guided pulmonary veins ablation.; Other: Esophageal temperature monitoring; Diagnostic test: Esophageal endoscopy; Other: High-power pulmonary veins ablation.

• Study Type: Observational
• Enrollment (Actual): 78

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Consecutive and unselected patients.

Description

Inclusion Criteria:

• Consecutive and unselected patients with a class I-IIa indication for ablation of paroxysmal or persistent AF.
• Informed consent.

Exclusion Criteria:

• Previous surgical or catheter-based PVI.
• Stroke or acute coronary syndrome <6 months before ablation.
• Terminal comorbidities.
• Frailty, or clinical instability.
• Absolute contraindication for oral anticoagulation.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Conventional ablation (CONTROL GROUP); Pulmonary veins ablation.; Anterior aspect: power 30 W, catheter dragging (30 s per point).; Posterior aspect: point-by-point ablation using 30 W/30 s applications. If esophageal temperature measured with two independent esophageal probes exceeded 49 ºC radiofrequency settings were modified to 20 W/ 60 s and the number of radiofrequency applications minimized in areas with esophageal temperature rise. Al procedures were performed with continuos intracardiac echo image and esophageal temperature monitoring.	Other: Conventional LSI/AI-guided pulmonary veins ablation.; Conventional (low-power and long-duration) radiofrequency application.; Other: Esophageal temperature monitoring; Two probes were simultaneously used: a deflectable one and a non-deflectable one.; Diagnostic test: Esophageal endoscopy; Esophageal endoscopy for acute detection of esophageal thermal lesions <72 hours after ablation.
High-power and short-duration ablation; Pulmonary veins ablation.; Subgroup 50W: power 50 W, application duration ≤ 30 s, target lesion index: LSI ≥ 5 or Ablation Index ≥ 350 (posterior wall) or ≥400 (anterior wall).; Subgroup 60W: power 60 W, application duration 7-10 s, contact force ≥5 g.; Subgroup 70W: power 70 W, application duration 9 s, contact force ≥5 g. Intracardiac echo was not used. Esophageal temperature probes were used only in 6 patients in the subgroup 50W.	Diagnostic test: Esophageal endoscopy; Esophageal endoscopy for acute detection of esophageal thermal lesions <72 hours after ablation.; Other: High-power pulmonary veins ablation.; Experimental (high-power and short-duration) radiofrequency application.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical feasibility (systematic use of the high-power and short-duration technique)	Feasibility of the high-power and short-duration radiofrequency technique.	Intraprocedural.
Incidence of complications	Incidence of esophageal thermal lesiones.	< 72 hours after ablation.
Acute efficacy	Acute pulmonary veins isolation, first-pass isolation, acute reconnections and dormant conduction.	Intraprocedural
1-year efficacy	Recurrence of atrial arrhythmias >30 seconds	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total radiofrequency time	Total radiofrequency time needed for definitive isolation of all pulmonary veins	Intraprocedural

Collaborators and Investigators

• Sponsor: Hospital Universitario La Paz

Publications and helpful links

General Publications

• Castrejon-Castrejon S, Martinez Cossiani M, Ortega Molina M, Escobar C, Froilan Torres C, Gonzalo Bada N, Diaz de la Torre M, Suarez Parga JM, Lopez Sendon JL, Merino JL. Feasibility and safety of pulmonary vein isolation by high-power short-duration radiofrequency application: short-term results of the POWER-FAST PILOT study. J Interv Card Electrophysiol. 2020 Jan;57(1):57-65. doi: 10.1007/s10840-019-00645-5. Epub 2019 Nov 12.

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2017
• Primary Completion (Actual): April 5, 2019
• Study Completion (Actual): April 5, 2020

Study Registration Dates

• First Submitted: November 11, 2019
• First Submitted That Met QC Criteria: November 11, 2019
• First Posted (Actual): November 14, 2019

Study Record Updates

• Last Update Posted (Actual): September 14, 2021
• Last Update Submitted That Met QC Criteria: September 7, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Atrial fibrillation; Radiofrequency; Ablatión; High-power; Esophageal lesion
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Atrial Fibrillation; Arrhythmias, Cardiac; Tachycardia
• Other Study ID Numbers: PI-3271

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