Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial - Star AF II Study

Abbott

Status

Completed

Conditions

Atrial Fibrillation

Treatments

Procedure: PVI + Lines ablation

Procedure: PVI

Procedure: PVI + CFE ablation

Study type

Interventional

Funder types

Industry

Identifiers

NCT01203748

AF-09-102-ID-AB

Details and patient eligibility

About

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 the Wide Circumferential Pulmonary Vein Antrum Isolation (PVI) approach and to the Combined PV Antral Isolation and Empiric Linear Ablation (PVI+Lines) approach.

Enrollment

589 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.