An observational study in Cardiac Arrhythmia, Atrial Fibrillation and Atrial Tachycardia, sponsored by Hospital Universitario La Paz. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-14.
Sponsored by Hospital Universitario La Paz · Observational
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:
The safety endpoint was evaluated with systematic esophageal endoscopy performed \<72 h after the index procedure. The efficacy endpoint was evaluated:
915 studies on the registry are indexed under Arrhythmias, Cardiac; 234 are open to participants now.
This study's enrollment of 78 is below the median of 200 across 426 observational studies indexed under Arrhythmias, Cardiac.
Browse Arrhythmias, Cardiac studies →Hospital Universitario La Paz is the lead sponsor of 55 studies on the registry; 19 are open to participants now.
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Consecutive and unselected patients.
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Exclusion Criteria:
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. · Other: Esophageal temperature monitoring · Diagnostic Test: Esophageal endoscopy
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.
Other: High-power pulmonary veins ablation. · Diagnostic Test: Esophageal endoscopy
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.
Clinical feasibility (systematic use of the high-power and short-duration technique)
Feasibility of the high-power and short-duration radiofrequency technique.
Time frame: Intraprocedural.
Incidence of complications
Incidence of esophageal thermal lesiones.
Time frame: < 72 hours after ablation.
Acute efficacy
Acute pulmonary veins isolation, first-pass isolation, acute reconnections and dormant conduction.
Time frame: Intraprocedural
1-year efficacy
Recurrence of atrial arrhythmias \>30 seconds
Time frame: One year
Total radiofrequency time
Total radiofrequency time needed for definitive isolation of all pulmonary veins
Time frame: Intraprocedural
Plan to share: No
Ran from Sep 2017 to primary completion in Apr 2019, 18 months.
Of 181 non-industry observational studies under Arrhythmias, Cardiac, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 109. This study's 18 months is below that.
Counting every sponsor, half of 243 studies reached it within 37 months; a quarter within 15 and three quarters within 91.
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This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Hospital Universitario La Paz