Status:
COMPLETED
STAR-AF:Substrate Versus Trigger Ablation for Reduction of Atrial Fibrillation Trial
Lead Sponsor:
Abbott Medical Devices
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Patient Population: Patients with AF that is symptomatic and refractory to at least one antiarrhythmic medication. Patients must have AF that is paroxysmal (\>4 episodes within 6 months, two episodes ...
Detailed Description
Interventions: Patients will be randomized to either wide circumferential pulmonary vein isolation ("trigger") or ablation of high-frequency, fractionated electrograms during AF ("substrate"), or a hy...
Eligibility Criteria
Inclusion
- Patients age 18 or greater.
- "high burden" of paroxysmal atrial fibrillation or persistent atrial fibrillation
- candidates for AF ablation based on AF that is symptomatic and refractory to at least one antiarrhythmic medication.
- At least one episode of AF must have been documented by ECG or Holter within 12 months of randomization in the trial.
- continuous anticoagulation with warfarin (INR 2-3) for \>4 weeks prior to the ablation.
- Patients must be able and willing to provide written informed consent to participate in the clinical trial.
Exclusion
- chronic atrial fibrillation.
- Patients with AF felt to be secondary to an obvious reversible cause.
- inadequate anticoagulation as defined in the inclusion criteria.
- left atrial thrombus or spontaneous echo contrast on TEE prior to procedure.
- contraindications to systemic anticoagulation with heparin or coumadin.
- previously undergone atrial fibrillation ablation.
- left atrial size \> 55 mm.
- Patients who are or may potentially be pregnant
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT00367757
Start Date
August 1 2006
End Date
July 1 2009
Last Update
January 30 2019
Active Locations (8)
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1
Southlake Regional Health Centre
Newmarket, Ontario, Canada, L3Y 2P9
2
Montreal Heaert Institute
Montreal, Quebec, Canada, H1T 1C8
3
McMaster University
Hamilton, Canada, L8L 2X2
4
Victoria Cardiac Arrhythmia Trials Inc - Royal Jubilee
Victoria, Canada, V8R 4R2