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

N/ACompletedNCT01203748

Abbott Medical Devices589 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

589

Conditions

Atrial Fibrillation

Interventions

PVI + Lines ablationPROCEDURE

Pulmonary vein antrum isolation with additional linear ablation (mitral line and roof line)

PVIPROCEDURE

Pulmonary vein antrum isolation

PVI + CFE ablationPROCEDURE

Pulmonary vein antrum isolation with additional complex fractionated electrogram ablation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

St. Andrews War Memorial Hospital

Brisbane, Queensland, Australia

Southlake Regional Health Centre

Newmarket, Ontario, Canada

Outcomes

Primary Outcomes

Freedom from AF

Freedom from documented AF episodes \> 30 seconds at 18 months after one or two ablation procedure with/without antiarrhythmic medications (AAD). In the CT.gov website and in our protocol, we have stated the above primary endpoint (PE). This was the identical PE used in the original STAR AF I study. The intent of this PE was to present the success rates after both 1 procedure and after 2 procedures separately as was done in the original STAR AF I study. However, this is not entirely clear from the way the PE is stated. It may appear that our PE is the success rate after 2 procedures ("1 or 2" may imply "2"). Since our sample size calculation for the STAR AF II study was based on a single procedure success rate, the single procedure success rate with/without AAD will be used as the PE. The success rate after 2 procedures will be provided as the 1st. secondary endpoint. This clarification is done prior to locking the database and prior to any data analysis.

Time frame: 18 months

Secondary Outcomes

Freedom from atrial arrhythmia

Freedom from documented atrial arrhythmia episodes \> 30 seconds at 18 months after one or two ablation procedures with/without antiarrhythmic medications

Time frame: 18 months

Freedom from atrial flutter and AT

Freedom from documented atrial flutter and atrial tachycardia episodes \> 30 seconds at 18 months after one and two procedures with/without antiarrhythmic medications

Time frame: 18 months

Freedom from documented or not atrial arrhythmia

Freedom from any atrial arrhythmia (documented or not) episodes \> 30 seconds at 18 months after one or two ablation procedures with/without antiarrhythmic medications

Time frame: 18 months

Freedom from symptomatic AF

Freedom from symptomatic AF episodes \> 30 seconds at 18 months after one or two ablation procedures with/without antiarrhythmic medications

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.