NCT00367757

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
PROCEDURE	Ablate AF triggers via PVI	Trigger-based ablation guided by pulmonary vein antrum isolation
PROCEDURE	Substrate via CFAEs	Substrate-based ablation using an approach targeting CFAEs
PROCEDURE	Combined approach for AF ablation	Combined trigger and substrate based approach

Timeline

• Start date: 2006-08-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2006-08-23
• Last updated: 2019-01-30

Locations

8 sites across 4 countries: Canada, Italy, Norway, Spain