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

Atrial Fibrillation Clinical Trial

— POWER_FAST  

Official title:

Feasibility, Safety and Mid-term Efficacy of Pulmonary Vein Isolation by High-power Short-duration Radiofrequency Application: the POWER FAST Pilot Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04162249
• Other study ID #: PI-3271
• Status: Completed
• Start date: September 15, 2017
• Est. completion date: April 5, 2020

Study information

• Verified date: September 2021
• Source: Hospital Universitario La Paz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: April 5, 2020
• Est. primary completion date: April 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Atrial Fibrillation
• Atrial Tachycardia
• Cardiac Arrhythmia
• Esophagus Injury
• Tachycardia

Intervention

Other:
• Conventional LSI/AI-guided pulmonary veins ablation.
Conventional (low-power and long-duration) radiofrequency application.
• High-power pulmonary veins ablation.
Experimental (high-power and short-duration) radiofrequency application.
• 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.

Locations

Country	Name	City	State
Spain	University Hospital La Paz, Department of Cardiology	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario La Paz

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Castrejón-Castrejón S, Martínez Cossiani M, Ortega Molina M, Escobar C, Froilán Torres C, Gonzalo Bada N, Díaz de la Torre M, Suárez Parga JM, López Sendón JL, Merino JL. Feasibility and safety of pulmonary vein isolation by high-power short-duration radi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical feasibility (systematic use of the high-power and short-duration technique)	Feasibility of the high-power and short-duration radiofrequency technique.	Intraprocedural.
Primary	Incidence of complications	Incidence of esophageal thermal lesiones.	< 72 hours after ablation.
Primary	Acute efficacy	Acute pulmonary veins isolation, first-pass isolation, acute reconnections and dormant conduction.	Intraprocedural
Primary	1-year efficacy	Recurrence of atrial arrhythmias >30 seconds	One year
Secondary	Total radiofrequency time	Total radiofrequency time needed for definitive isolation of all pulmonary veins	Intraprocedural