Status:
COMPLETED
Randomized Trial of Segmental Versus Circumferential Antral Ablation in Paroxysmal Atrial Fibrillation
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Conditions:
Paroxysmal Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
An isolation-limited segmental antral approach to pulmonary vein isolation is as effective in achieving long-term freedom from atrial fibrillation as the standard anatomic, circumferential antral abla...
Detailed Description
This is a randomized controlled non-inferiority designed trial. Follow up: Patients will stop their anti-arrhythmic drugs 2 months post procedure. Follow-ups will involve clinical assessment, holter...
Eligibility Criteria
Inclusion
- Paroxysmal Atrial Fibrillation (PAF) for at least 6 months with at least 1 symptomatic episode during the previous 6 moths
- Patient must be felt to be candidates for Atrial Fibrillation (AF) ablation based on AF that is symptomatic and refractory or intolerant to at least one class 1 or 3 anti-arrhythmic agent
- Documentation of at least one episode of AF on 12 lead ECG, TTM or Holter monitor within 12 months of randomization in the trial
- Patient must be on continuous anti-coagulation with warfarin (INR 2-3) or fractionated subcutaneous heparin for \>4 weeks prior to the ablation or they have undergone a recent (less than 48 hours before planned ablation) transoesphageal echocardiogram to exclude left atrial thrombus.
- Patient must provide written informed consent to participate in the clinical trial
Exclusion
- Contraindications to oral anticoagulants
- History of any previous ablation for AF
- Intracardiac thrombus
- AF due to reversible causes
- Pregnancy
- atriotomy scar (typically, MV or TV repair/replacement, ASD surgery, transplants)(CABG are okay)
Key Trial Info
Start Date :
November 12 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2015
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01260220
Start Date
November 12 2009
End Date
December 31 2015
Last Update
August 28 2017
Active Locations (1)
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1
London Health Science Centre
London, Ontario, Canada, N6A 5A5