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POWER_FAST
Feasibility, Safety and Mid-term Efficacy of Pulmonary Vein Isolation by High-power Short-duration Radiofrequency Application: the POWER FAST Pilot Study.
Sponsor study identifier
observational
78
1 country
1
Study Start
September 15, 2017
Actual (reported)Primary Completion
April 5, 2019
Actual (reported)Study Completion
April 5, 2020
Actual (reported)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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 5, 2020
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 15, 2017
Actual (reported)April 5, 2019
Actual (reported)November 11, 2019
Actual (reported)November 14, 2019
Actual (reported)April 5, 2020
Actual (reported)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
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.
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.
Conventional (low-power and long-duration) radiofrequency application.
Experimental (high-power and short-duration) radiofrequency application.
Consecutive and unselected patients.
University Hospital La Paz, Department of Cardiology
Madrid, Spain
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.
78 participants (actual enrollment reported by the registry).
First Submitted
November 11, 2019
First Posted
November 14, 2019
Study Start
September 15, 2017
Actual (reported)1-year efficacy
Recurrence of atrial arrhythmias \>30 seconds
One year
Total radiofrequency time
Intraprocedural
Two probes were simultaneously used: a deflectable one and a non-deflectable one.
Esophageal endoscopy for acute detection of esophageal thermal lesions \<72 hours after ablation.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
April 5, 2019
Actual (reported)Study Completion
April 5, 2020
Actual (reported)Last Updated
September 14, 2021
Record last verified: 2021-09
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Source: ClinicalTrials.gov.
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