Status:
COMPLETED
Kansai Plus Atrial Fibrillation Trial
Lead Sponsor:
Kyoto University, Graduate School of Medicine
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
21-79 years
Phase:
PHASE4
Brief 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). Th...
Detailed Description
Atrial fibrillation (AF) is a common tachyarrhythmia causing disabling symptoms and stroke. Although catheter ablation has been developed as curative therapy for AF, it is still associated with consid...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2017
Estimated Enrollment :
2113 Patients enrolled
Trial Details
Trial ID
NCT01477983
Start Date
November 1 2011
End Date
July 1 2017
Last Update
August 18 2017
Active Locations (1)
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1
Division of Cardiology, Kyoto University Hospital
Kyoto, Japan, 606-8507