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

NCT04162249 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 78

Last updated 2021-09-14

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Hospital Universitario La Paz

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-15
Primary Completion
2019-04-05
Completion
2020-04-05

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04162249 on ClinicalTrials.gov