STAR-AF:Substrate Versus Trigger Ablation for Reduction of Atrial Fibrillation Trial
Atrial Fibrillation
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring paroxysmal atrial fibrillation, persistent atrial fibrillation, high burden of atrial fibrillation, atrial fibrillation ablation, Pulmonary vein isolation, AF trigger, complex fractionated electrograms, CFE, CFAE, complex fractionated atrial electrograms, refractory antiarrhythmic medication, PVAI, Ensite NavX, NavX, CoolPath catheter, irrigated ablation catheter, high burden of paroxysmal or persistent atrial fibrillation, candidates for AF ablation, symptomatic AF, AF is refractory to at least one antiarrhythmic medication
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Sites / Locations
- Southlake Regional Health Centre
- Montreal Heaert Institute
- McMaster University
- Victoria Cardiac Arrhythmia Trials Inc - Royal Jubilee
- Clinica Santa Maria
- Ospedale Regionale Ca'Foncello
- Haukeland Universitetssykehus
- Hospital General Universitario Gregorio Marañón
Arms of the Study
Arm 1
Arm 2
Arm 3
Other
Other
Other
PVI group
CFAE group
Combined group
Trigger-based ablation guided by pulmonary vein antrum isolation
Substrate-based ablation using an approach targeting CFAEs
Combined trigger and substrate based approach