STAR-AF:Substrate Versus Trigger Ablation for Reduction of Atrial Fibrillation Trial

Atrial Fibrillation Clinical Trial

Official title: Open, Prospective, Randomized Trial Comparing Trigger vs Substrate vs Hybrid Approaches for AF Ablation

Status Completed

Clinical Trial 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 >6 hours within 1 year) or persistent (sustained episode <6 months terminated by cardioversion or drug).

Purpose: To compare a trigger-based technique (pulmonary vein isolation) to a substrate-based technique (high-frequency, fractionated EGMs) to a combined approach for AF ablation

Clinical Trial 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 hybrid approach combining trigger and substrate. Both techniques will be performed with NavX mapping system and a standardized ablation catheter. Endpoint of PVI will be isolation of all four PVs documented by circular catheter. Endpoint for substrate-based ablation will be termination and noninducibility of AF. Up to 2 procedures will be allowed within 6 months. A 2 month blanking period will be allowed after each procedure during which early recurrences will not be counted.

Outcomes:

• Recurrence of atrial fibrillation or other atrial tachycardia at 3, 6, and 12 months post-initial procedure.

• Recurrence will be defined by symptoms and/or ECG/Holter data showing AF > 2 mins

• Occurrence of adverse events in each group post-procedure.

• Quality of life assessment at 6 and 12 months post-initial procedure.

Followup:

• 3, 6, and 12 months post-initial procedure.

• Clinical data, ECG, Holter, loop recorder at baseline and at each visit.

• QOL at baseline, 3, 6 and 12 months post-initial procedure. ;

Related Conditions & MeSH terms

• Atrial Fibrillation

• NCT number: NCT00367757
• Study type: Interventional
• Source: Abbott Medical Devices
• Status: Completed
• Phase: N/A
• Start date: August 2006
• Completion date: July 2009