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

PHASE4CompletedINTERVENTIONAL
Enrollment

182

Participants

Timeline

Start Date

March 24, 2021

Primary Completion Date

October 22, 2021

Study Completion Date

May 31, 2022

Conditions
Atrial Fibrillation
Interventions
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.

Trial Locations (4)

8000

AZ Sint-Jan Brugge-Oostende AV, Bruges

Unknown

Medical University Hospital Graz, Graz

UMC Leiden, Leiden

Luzerner Kantonsspital, Lucerne

All Listed Sponsors
lead

AZ Sint-Jan AV

OTHER

NCT04784013 - Very High Power Ablation in Patients With Atrial Fibrillation Scheduled for a First Pulmonary Vein Isolation | Biotech Hunter | Biotech Hunter