Kansai Plus Atrial Fibrillation Trial

• Status: Completed
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyoto University, Graduate School of Medicine
• Treatments: Adenosine; Anti-Arrhythmia Agents; Flecainide

Criteria

Inclusion Criteria:

• Patients undergoing first catheter ablation including PV isolation for paroxysmal or persistent atrial fibrillation

• Patients who are 21-79 years old

• Able to be followed for one year in an out-patient clinic

• Willing to sign the consent form for participation

Exclusion Criteria:

• Contraindication or intolerance to adenosine triphosphate or Vaughan Williams class I or III antiarrhythmic drugs, including severe bronchial asthma, severe vasospastic angina, and substantial bradycardia including sinus node dysfunction with prolonged pauses on termination of atrial fibrillation

• Age =< 20 years or => 80 years

• Renal insufficiency (serum creatinine >=2.0mg/dl or hemodialysis)

• NYHA class IV heart failure

• Left ventricular ejection fraction < 40%

• Left atrial diameter > 55mm

• Very long-lasting (>=5years) persistent atrial fibrillation

• Ineligible for optimal anticoagulant therapy

• History of myocardial infarction within the past 6 months

• Prior or planned open heart surgery

• Severe valve heart disease

• Unable to be followed in an out-patient clinic for one year

• Unwilling to sign the consent form for participation

• When the attending physician are unwilling to enroll the patient in the study

• When the attending physician consider inappropriate to enroll the patient in the study

• Those with severe procedural complications (EAST-AF trial only)