Clinical trial NCT04162249: High Radiofrequency Power for Faster and Safer Pulmonary Veins Isolation - a Pilot Observational Study.
Official title: Feasibility, Safety and Mid-term Efficacy of Pulmonary Vein Isolation by High-power Short-duration Radiofrequency Application: the POWER FAST Pilot Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrhythmia
Atrial Fibrillation
Atrial Tachycardia
Esophagus Injury
Keywords: Atrial fibrillation
Ablatión
High-power
Radiofrequency
Esophageal lesion
Lead sponsor: Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2019-11-14
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive and unselected patients.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Clinical feasibility (systematic use of the high-power and short-duration technique)
timeFrame: Intraprocedural.
measure: Incidence of complications
timeFrame: < 72 hours after ablation.
measure: Acute efficacy
timeFrame: Intraprocedural
measure: 1-year efficacy
timeFrame: One year
Secondary outcomes:
measure: Total radiofrequency time
timeFrame: Intraprocedural
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: University Hospital La Paz, Department of Cardiology
Study officials:
References:
citation: Castrejon-Castrejon S, Martinez Cossiani M, Ortega Molina M, Escobar C, Froilan Torres C, Gonzalo Bada N, Diaz de la Torre M, Suarez Parga JM, Lopez Sendon JL, Merino JL. Feasibility and safety of pulmonary vein isolation by high-power short-duration radiofrequency application: short-term results of the POWER-FAST PILOT study. J Interv Card Electrophysiol. 2020 Jan;57(1):57-65. doi: 10.1007/s10840-019-00645-5. Epub 2019 Nov 12.