Pulsed ElectRic FiEld Versus Cryoballoon for PAF

NACompletedINTERVENTIONAL
Enrollment

269

Participants

Timeline

Start Date

September 27, 2023

Primary Completion Date

May 30, 2024

Study Completion Date

June 30, 2025

Conditions
Atril FibrillationCardiac ArrhythmiaParoxysmal Atrial Fibrillation (PAF)
Interventions
DEVICE

Single-Shot Pulsed Field Ablation (FARAPULSE™ Pulsed Field Ablation System)

The FARAPULSE™ Pulsed Field Ablation System (Boston Scientific, Inc.) is a CE-marked system consisting of the FARASTAR™ Pulsed Field Ablation Generator that is used with the FARAWAVE™ Pulsed Field Ablation Catheter for cardiac tissue ablation

DEVICE

Single-Shot Cryoballoon Devices (Arctic Front Advance PRO, Medtronic Inc., Minneapolis, MN, USA; POLARx and POLARx FIT Balloon Catheter, Marlborough, MA, USA)

The Arctic Front Advance PRO, POLARx and FIT Balloon Catheters are CE-marked cryoablation systems consisting of a cryoballoon device, which is used in conjunction with a CryoConsole, a steerable sheath, and a circular mapping catheter

Trial Locations (6)

Unknown

Universitair Ziekenhuis Brussel, Brussels

Department of Cardiovascular Diseases, University Hospital Center Zagreb, Zagreb

9. First Department of Cardiology, National and Kapodistrian University of Athens Medical School, Hippokration General Hospital, Athens

Maria Cecilia Hospital, Cotignola

Ospedale Fatebenefratelli Isola Tiberina-Gemelli Isola, Roma

Department of Cardiology, Medical University of Lublin, Lublin

All Listed Sponsors
lead

Universitair Ziekenhuis Brussel

OTHER

NCT07100834 - Pulsed ElectRic FiEld Versus Cryoballoon for PAF | Biotech Hunter | Biotech Hunter