NCT04784013

Very High Power Ablation in Patients With Atrial Fibrillation Scheduled for a First Pulmonary Vein Isolation

Very High Power Ablation in Patients With Atrial Fibrillation Scheduled for a First Pulmonary Vein Isolation: the POWER-PLUS Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 182 (actual)
• Sponsor: AZ Sint-Jan AV · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This prospective, randomized, controlled, unblinded, multicenter study aims at comparing procedural time between conventional CLOSE-guided pulmonary vein isolation (PVI) (35W/50W) versus very high power radiofrequency delivery (90W) in atrial fibrillation patients scheduled for a first PVI.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
PROCEDURE	Conventional CLOSE-guided pulmonary vein isolation	Point-by-point RF delivery will be performed aiming for a contiguous circle enclosing the veins. RF will be delivered in a temperature and flow-controlled mode (QMODE, target temperature 45°C, low flow temperature 40°C, cut-off temperature 50°C) with a power of 35W(posterior)/50W(anterior) (irrigation flow at 4-15ml/min). RF will be delivered until an ablation index (AI) of ≥400 at the posterior wall/roof/south pole and ≥550 at the anterior wall.
PROCEDURE	High power short duration pulmonary vein isolation	Point-by-point RF delivery will be performed aiming for a contiguous circle enclosing the veins. RF will be delivered in temperature-controlled mode (QMode+, target temperature 55°C, cut-off temperature 65°C) with a power of 90W (irrigation flow at 2-8ml/min). RF will be delivered for 4 sec at both the posterior and anterior wall.

Timeline

• Start date: 2021-03-24
• Primary completion: 2021-10-22
• Completion: 2022-05-31
• First posted: 2021-03-05
• Last updated: 2022-06-21

Locations

4 sites across 4 countries: Austria, Belgium, Netherlands, Switzerland