SINGLE SHOT CHAMPION

PHASE4Active, not recruitingINTERVENTIONAL
Enrollment

210

Participants

Timeline

Start Date

September 26, 2022

Primary Completion Date

January 1, 2025

Study Completion Date

January 31, 2027

Conditions
Paroxysmal Atrial Fibrillation
Interventions
DEVICE

PVI using the Arctic Front Cryoballoon (Medtronic)

Patients randomized to the Arctic Front cryoballoon group will undergo PVI using the Arctic Front Cryoballoon (Medtronic). At the end of the procedure, an implantable cardiac monitor will be implanted for the purpose of continuous arrhythmia monitoring.

DEVICE

PVI using FARAPULSE Pulsed Field Ablation (Boston Scientific)

Patients randomized to the Pulsed Field Ablation group will undergo PVI using the FARAPULSE PFA system (Boston Scientific). At the end of the procedure, an implantable cardiac monitor will be implanted for the purpose of continuous arrhythmia monitoring.

Trial Locations (2)

3010

Inselspital, Bern University Hospital, Bern

4031

University Hospital Basel, Basel

All Listed Sponsors
collaborator

University of Bern

OTHER

lead

Insel Gruppe AG, University Hospital Bern

OTHER

NCT05534581 - SINGLE SHOT CHAMPION | Biotech Hunter | Biotech Hunter