High Radiofrequency Power for Faster and Safer Pulmonary Vein Ablation Trial (POWER FAST III)

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

Clinical Phase

NA

Total Enrollment

304 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-25

Study Completion Date

2023-12-30

Brief Summary

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Multicenter 1:1 randomized study. Two atrial fibrillation ablation strategies are compared: 1) conventional ablation using point-by-point radiofrequency applications with power 40 W guided by LSI \> 6 or AI \> 500 on the anterior aspect of pulmonary veins and power 25 W guided by LSI \>5 or AI \>350 on the posterior wall near the esophagus; 2) point-by-point RF applications with power set at 70 W and duration 9-10 s. The main objective of the trial is the incidence of esophageal lesions evaluated with systematic endoscopy and clinical efficacy evaluated with daily ECG transtelephonic transmissions during 1-year follow-up. Secondary objectives include total RF time and parameters of acute PV isolation efficacy (first-pass isolation, acute reconnections and dormant conduction).

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Detailed Description

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Multicenter 1:1 randomized study: Hospital Universitario La Paz, Madrid; Hospital Clínico Universitario San Carlos, Madrid; Hospital Clínico y Provincial de Barcelona, Barcelona; Complejo Hospitalario de Navarra, Pamplona; Hospital Clínico Universitario de Valladolid; Hospital Clínico Universitario de Albacete; Hospital Clínico Universitario de Alicante; Hospital Universitario Virgen de las Nieves, Granada; Hospital La Fe, Valencia; Hospital Clínico de Valencia; Hospital Universitario Juan Ramón Jiménez, Huelva; Hospital de la Ribera, Alzira, Valencia. España. Spain.

Two atrial fibrillation ablation strategies are compared: 1) conventional ablation using point-by-point radiofrequency applications with power 40 W guided by LSI \> 6 or AI \> 500 on the anterior aspect of pulmonary veins and power 25-40 W guided by LSI \>5 or AI \>350 on the posterior wall near the esophagus; 2) point-by-point RF applications with power set at 70 W and duration 9-10 s.

The main objective of the trial is the incidence of esophageal lesions evaluated with systematic endoscopy and clinical efficacy evaluated with daily ECG transtelephonic transmissions during 1-year follow-up. Secondary objectives include total RF time and parameters of acute PV isolation efficacy (first-pass isolation, acute reconnections and dormant conduction).

Subestudy: asymptomatic cerebral lesions detected by 1,5 T MRI \<72 h after ablation. Not all centers participate in the subestydy. However, if the center participates, all patients in both ablation groups will be included in the subestudy.

Conditions

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Atrial Fibrillation Catheter Ablation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Conventional ablation

Point-by-point catheter-based pulmonary veins isolation using convencional radiofrequency parameters.

* Anterior aspect of pulmonary veins: 40 W, temperature limit 45 ºC, irrigation 17-30 ml/min; objective LSI\>=6 or Ablation index \>=500.
* Posterior aspect of pulmonary veins: 20-40 W, temperature limit 45 ºC, irrigation 17-3 ml/min; objective LSI\>=5 or Ablation index \>=350.

Group Type ACTIVE_COMPARATOR

Low-power (25-40 W) radiofrequency ablation guided by lesion size index (LSI) and ablation index (AI) values

Intervention Type OTHER

Pulmonary veins electrical isolation: low-power ablation.

Esophageal endoscopy

Intervention Type OTHER

Esophageal endoscopy to detect postablation esophageal thermal lesions.

Daily 30-seconds ECG

Intervention Type DIAGNOSTIC_TEST

Transtelephonic daily 30-seconds single lead electrocardiogram

High-power and short-duration ablation

Point-by-point catheter-based pulmonary veins isolation using high-power and short duration radiofrequency: 70 W, duration per application 9-10 s (initial ramp 2-3 s according to the technical characterictics of radiofrequency sources), temperature limit 45 ºC, irrigation 17 ml/min, contac-force \> 5 g.

Group Type EXPERIMENTAL

High-power and short-duration radiofrequency ablatio (70 W / 9-10 s)

Intervention Type OTHER

Pulmonary veins electrical isolation: high-power and short-duration ablation

Esophageal endoscopy

Intervention Type OTHER

Esophageal endoscopy to detect postablation esophageal thermal lesions.

Daily 30-seconds ECG

Intervention Type DIAGNOSTIC_TEST

Transtelephonic daily 30-seconds single lead electrocardiogram

Interventions

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High-power and short-duration radiofrequency ablatio (70 W / 9-10 s)

Pulmonary veins electrical isolation: high-power and short-duration ablation

Intervention Type OTHER

Low-power (25-40 W) radiofrequency ablation guided by lesion size index (LSI) and ablation index (AI) values

Pulmonary veins electrical isolation: low-power ablation.

Intervention Type OTHER

Esophageal endoscopy

Esophageal endoscopy to detect postablation esophageal thermal lesions.

Intervention Type OTHER

Daily 30-seconds ECG

Transtelephonic daily 30-seconds single lead electrocardiogram

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Transtelephonic daily 30-seconds single lead electrocardiogram

Eligibility Criteria

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Inclusion Criteria

* Paroxysmal or persistent atrial fibrillation.
* Currently accepted class I or II indication for ablation according to practice guidelines: symptomatic arrhythmia, failure of at least 1 antiarrhythmic drug or patient's manifest preference of ablation instead of drugs.
* Age \> 18 years.
* Acceptance of informed consent.

Exclusion Criteria

* Previous pulmonary veins ablation of any type.
* Permanent atrial fibrillation or long-standing persistent AF (\>1 year).
* Heart surgery \<3 months before ablation.
* Coronary revascularization of any type \<3 months before ablation.
* Myocardial infarction or acute coronary syndrome \< 3 months before ablation.
* Stroke or transient cerebral ischaemic attack \< 3 months before ablation.
* Persistent left atrial thrombus.
* Contraindication for anticoagulation.
* Absolute indication of double antiplatelet drugs.
* Complex congenital heart disease, corrected or not.
* Any clinical situation absolutely precluding an interventional procedure.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No