Kansai Plus Atrial Fibrillation Trial

PHASE4CompletedINTERVENTIONAL
Enrollment

2,113

Participants

Timeline

Start Date

November 30, 2011

Primary Completion Date

July 31, 2017

Study Completion Date

July 31, 2017

Conditions
Atrial Fibrillation
Interventions
PROCEDURE

ATP guide additional ablation.

Following successful PV isolation, intravenous ATP of 0.4 mg/body-weight-kg is rapidly is injected, and dormant LA-PV conduction is evaluated. If dormant LA-PV conduction is unmasked, then additional radiofrequency energy applications are delivered to the conduction gaps until disappearance of dormant LA-PV conduction.

DRUG

Antiarrhythmic drug (AAD)

Following successful ablation, AAD (Vaughan Williams class I or III) is administered for 90 days. The recommended drugs are flecainide, propafenone, sotalol and amiodarone, but the final choice of drug and dosage is left to the discretion of the attending physician.

PROCEDURE

ATP guide additional ablation.

Following successful PV isolation, intravenous ATP of 0.4 mg/body-weight-kg is rapidly is injected, and dormant LA-PV conduction is evaluated. If dormant LA-PV conduction is unmasked, then additional radiofrequency energy applications are delivered to the conduction gaps until disappearance of dormant LA-PV conduction.

DRUG

Control

Following successful ablation, AAD (Vaughan Williams class I or III) including flecainide, propafenone, sotalol and amiodarone is not used during the period of 0 - 90 days.

PROCEDURE

Control

Following successful PV isolation, intravenous ATP is not administered.

DRUG

Antiarrhythmic drug (AAD)

Following successful ablation, AAD (Vaughan Williams class I or III) is administered for 90 days. The recommended drugs are flecainide, propafenone, sotalol and amiodarone, but the final choice of drug and dosage is left to the discretion of the attending physician.

PROCEDURE

Control

Following successful PV isolation, intravenous ATP is not administered.

DRUG

Control

Following successful ablation, AAD (Vaughan Williams class I or III) including flecainide, propafenone, sotalol and amiodarone is not used during the period of 0 - 90 days.

Trial Locations (1)

606-8507

Division of Cardiology, Kyoto University Hospital, Kyoto

All Listed Sponsors
lead

Kyoto University, Graduate School of Medicine

OTHER

NCT01477983 - Kansai Plus Atrial Fibrillation Trial | Biotech Hunter | Biotech Hunter