drugset / Trial / NCT01477983

Kansai Plus Atrial Fibrillation Trial

NCT01477983

Phase 4 Completed 2113 enrolled Kyoto University, Graduate School of Medicine
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a 2x2 factorial randomized controlled trial (KPAF Trial), evaluating two different pharmacological approaches to improve long-term outcome of catheter ablation for atrial fibrillation (AF). The study is composed of UNmasking Dormant Electrical Reconduction by Adenosine TriPhosphate (UNDER-ATP) Trial and Efficacy of Antiarrhythmic Drugs Short-Term Use after Catheter Ablation for Atrial Fibrillation (EAST-AF) Trial. Patients with paroxysmal or persistent AF will be randomized to ATP guide ablation or control group in a 1:1 ratio before the procedure (UNDER-ATP Trial). Excluding those with severe procedural complications or substantial bradycardia identified first after ablation for persistent AF, patients will be randomized in a 1:1 ratio to antiarrhythmic-drug (AAD) or control group after the procedure (EAST-AF Trial).

Timeline

Start
2011-11
Primary completion
2017-07
Completion
2017-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Amiodarone Small molecule
Comparator flecainide Small molecule
Comparator propafenone Unknown
Comparator sotalol Small molecule

Indications