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Completed

NCT Number: NCT04162249

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital La Paz, Department of Cardiology

Madrid, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Consecutive and unselected patients with a class I-IIa indication for ablation of paroxysmal or persistent AF.
  • Informed consent.

Exclusion criteria

  • Previous surgical or catheter-based PVI.
  • Stroke or acute coronary syndrome <6 months before ablation.
  • Terminal comorbidities.
  • Frailty, or clinical instability.
  • Absolute contraindication for oral anticoagulation.

Treatment and study plan

Conventional LSI/AI-guided pulmonary veins ablation.

Other

Conventional (low-power and long-duration) radiofrequency application.

High-power pulmonary veins ablation.

Other

Experimental (high-power and short-duration) radiofrequency application.

Esophageal temperature monitoring

Other

Two probes were simultaneously used: a deflectable one and a non-deflectable one.

Esophageal endoscopy

Diagnostic Test

Esophageal endoscopy for acute detection of esophageal thermal lesions <72 hours after ablation.

Primary outcomes

  1. Clinical feasibility (systematic use of the high-power and short-duration technique)

    Time frame: Intraprocedural.

    Feasibility of the high-power and short-duration radiofrequency technique.

  2. Incidence of complications

    Time frame: < 72 hours after ablation.

    Incidence of esophageal thermal lesiones.

  3. Acute efficacy

    Time frame: Intraprocedural

    Acute pulmonary veins isolation, first-pass isolation, acute reconnections and dormant conduction.

  4. 1-year efficacy

    Time frame: One year

    Recurrence of atrial arrhythmias >30 seconds

Secondary outcomes

  1. Total radiofrequency time

    Time frame: Intraprocedural

    Total radiofrequency time needed for definitive isolation of all pulmonary veins

Sponsors and collaborators

Lead sponsor

Hospital Universitario La Paz

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Nov 14, 2019
Registry last updated
Sep 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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