University Hospital La Paz, Department of Cardiology
Madrid, Spain
NCT Number: NCT04162249
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.
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Notify Me18 year and older
All sexes
Observational
Madrid, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Conventional (low-power and long-duration) radiofrequency application.
Experimental (high-power and short-duration) radiofrequency application.
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.
Time frame: Intraprocedural.
Feasibility of the high-power and short-duration radiofrequency technique.
Time frame: < 72 hours after ablation.
Incidence of esophageal thermal lesiones.
Time frame: Intraprocedural
Acute pulmonary veins isolation, first-pass isolation, acute reconnections and dormant conduction.
Time frame: One year
Recurrence of atrial arrhythmias >30 seconds
Time frame: Intraprocedural
Total radiofrequency time needed for definitive isolation of all pulmonary veins
Hospital Universitario La Paz
Other
Feasibility, Safety and Mid-term Efficacy of Pulmonary Vein Isolation by High-power Short-duration Radiofrequency Application: the POWER FAST Pilot Study.
Acronym: POWER_FAST
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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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