NCT04162249

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 78 (actual)
• Sponsor: Hospital Universitario La Paz · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Cardiac Arrhythmia
• Atrial Fibrillation
• Atrial Tachycardia
• Esophagus Injury

Interventions

Type	Name	Description
OTHER	Conventional LSI/AI-guided pulmonary veins ablation.	Conventional (low-power and long-duration) radiofrequency application.
OTHER	High-power pulmonary veins ablation.	Experimental (high-power and short-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.

Timeline

• Start date: 2017-09-15
• Primary completion: 2019-04-05
• Completion: 2020-04-05
• First posted: 2019-11-14
• Last updated: 2021-09-14

Locations

1 site across 1 country: Spain