High Radiofrequency Power for Faster and Safer Pulmonary Veins Isolation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

78 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-15

Study Completion Date

2020-04-05

Brief Summary

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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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Detailed Description

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Conditions

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Cardiac Arrhythmia Atrial Fibrillation Atrial Tachycardia Esophagus Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Conventional ablation (CONTROL GROUP)

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.

Conventional LSI/AI-guided pulmonary veins ablation.

Intervention Type OTHER

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

Esophageal temperature monitoring

Intervention Type OTHER

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

Esophageal endoscopy

Intervention Type DIAGNOSTIC_TEST

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

High-power and short-duration ablation

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.

High-power pulmonary veins ablation.

Intervention Type OTHER

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

Esophageal endoscopy

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Conventional LSI/AI-guided pulmonary veins ablation.

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

Intervention Type OTHER

High-power pulmonary veins ablation.

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

Intervention Type OTHER

Esophageal temperature monitoring

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

Intervention Type OTHER

Esophageal endoscopy

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No