Status:
COMPLETED
Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial - Star AF II Study
Lead Sponsor:
Abbott Medical Devices
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This investigation is designed with the hypothesis that combined PV Antral Isolation and Ablation of Complex Fractionated Electrograms (PVI+CFE) approach will offer a higher success rate compared to t...
Eligibility Criteria
Inclusion
- Patients age is18 years or greater;
- Patients undergoing a first-time ablation procedure for AF;
- Patients with persistent AF;
- Persistent AF will be defined as a sustained episode lasting \> 7 days and less than 3 years.
- Patients with symptomatic AF that is refractory to at least one antiarrhythmic medication;
- At least one episode of persistent AF must have been documented by ECG, holter, loop recorder, telemetry, trans telephonic monitoring (TTM), or implantable device within last 2 years of enrollment in this investigation;
- Patients must be able and willing to provide written informed consent to participate in this investigation; and
- Patients must be willing and able to comply with all peri-ablation and follow-up requirements.
Exclusion
- Patients with paroxysmal AF;
- Patients with long-standing persistent AF;
- Patients for whom cardioversion or sinus rhythm will never be attempted/pursued;
- Patients with AF felt to be secondary to an obvious reversible cause;
- Patients with contraindications to systemic anticoagulation with heparin or coumadin or a direct thrombin inhibitor;
- Patients with left atrial size ≥ 60 mm (2D echocardiography, parasternal long axis view); and
- Patients who are pregnant.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
589 Patients enrolled
Trial Details
Trial ID
NCT01203748
Start Date
November 1 2010
End Date
January 1 2014
Last Update
January 30 2019
Active Locations (2)
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1
St. Andrews War Memorial Hospital
Brisbane, Queensland, Australia
2
Southlake Regional Health Centre
Newmarket, Ontario, Canada, L3Y 8C3