CLOSE-guided Pulmonary Vein Isolation Using High Power and Stable RF Applications — POWERAF  

Atrial Fibrillation Clinical Trial

Official title: CLOSE-guided Pulmonary Vein Isolation Using High Power and Stable RF Applications: a Randomized Study. The POWERAF Study

Status Completed

Clinical Trial Summary

In this prospective, randomised, controlled, unblinded,monocentric study, we aim to evaluate the safety and efficacy of higher power CLOSE-guided PVI in patients referred for a first ablation for paroxysmal AF. We aim to include 100 patients into two groups (1:1). The experimental group will receive AF ablation with 45 Watt and stricter stability criteria (3 mm for 3 seconds) compared to the control group which will receive AF ablation according to the standard CLOSE-protocol (35 Watt and stability criteria of 3 mm for 8 seconds).

Clinical Trial Description

BACKGROUND: In a population of paroxysmal AF 'CLOSE'-guided PVI (Target Ablation index (AI) >550 and >400 for anterior and posterior wall respectively, interlesion distance ≤6mm) has been shown to obtain single-procedure durable PV isolation. However, the optimal RF power and stability criteria is unknown.

OBJECTIVES: With this study, we aim at evaluation the efficacy and the safety of higher power (45 watts) and stricter stability criteria (3 mm for 3 sec) as compared to a standard CLOSE protocol (35 watts with stability of 3 mm for 8 sec) in patients referred for a first ablation for paroxysmal AF.

POPULATION: Eligible patients are patients with paroxysmal AF who are planned for a 'CLOSE'-guided PV isolation for paroxysmal AF. At the time of the procedrual planning, we will ask the patient his/her consent for collectio of data. We aim at including 100 patients. ;

Related Conditions & MeSH terms

• Atrial Fibrillation

• NCT number: NCT04122963
• Study type: Interventional
• Source: AZ Sint-Jan AV
• Status: Completed
• Phase: N/A
• Start date: February 15, 2019
• Completion date: June 30, 2020