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

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Procedure: Ablate AF triggers via PVI; Procedure: Combined approach for AF ablation; Procedure: Substrate via CFAEs

• Registration Number: NCT00367757
• Lead Sponsor: Abbott Medical Devices

Brief 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.

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2006-08-22
• Study First Submitted QC: 2006-08-22
• Study First Posted: 2006-08-23
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-28
• Last Update Posted: 2019-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

• Patients age 18 or greater.
• "high burden" of paroxysmal atrial fibrillation or persistent atrial fibrillation
• candidates for AF ablation based on AF that is symptomatic and refractory to at least one antiarrhythmic medication.
• At least one episode of AF must have been documented by ECG or Holter within 12 months of randomization in the trial.
• continuous anticoagulation with warfarin (INR 2-3) for >4 weeks prior to the ablation.
• Patients must be able and willing to provide written informed consent to participate in the clinical trial.

Exclusion Criteria

• chronic atrial fibrillation.
• Patients with AF felt to be secondary to an obvious reversible cause.
• inadequate anticoagulation as defined in the inclusion criteria.
• left atrial thrombus or spontaneous echo contrast on TEE prior to procedure.
• contraindications to systemic anticoagulation with heparin or coumadin.
• previously undergone atrial fibrillation ablation.
• left atrial size > 55 mm.
• Patients who are or may potentially be pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PVI group	Ablate AF triggers via PVI	Trigger-based ablation guided by pulmonary vein antrum isolation
Combined group	Combined approach for AF ablation	Combined trigger and substrate based approach
CFAE group	Substrate via CFAEs	Substrate-based ablation using an approach targeting CFAEs

Primary Outcome Measures

Name	Time	Method
Freedom from atrial fibrillation at 3 months post-first ablation procedure off antiarrhythmic medications.	3 months
Freedom from atrial fibrillation at 6 and 12 months post-first ablation procedure off antiarrhythmic medications.	12 months

Secondary Outcome Measures

Name	Time	Method
Fluoroscopy time at ablation.	At intervention
Incidence of peri-procedural complications including stroke, PV stenosis, cardiac perforation, esophageal injury, and death.	12 months
Procedure duration at ablation.	At intervention
Quality of life measurements (SF-36) at baseline, 3, 6 and 12 months post-first procedure.	12 months
Freedom from atrial fibrillation on or off antiarrhythmic medications at 3, 6 and 12 months post-first ablation procedure.	12 months
Freedom from atrial fibrillation and other atrial arrhythmias at 3, 6 and 12 months post-first ablation procedure.	12 months

Trial Locations

Locations (8)

Montreal Heaert Institute; 🇨🇦 Montreal, Quebec, Canada

Southlake Regional Health Centre; 🇨🇦 Newmarket, Ontario, Canada

Hospital General Universitario Gregorio Marañón; 🇪🇸 Madrid, Spain

Haukeland Universitetssykehus; 🇳🇴 Bergen, Haukeland, Norway

Ospedale Regionale Ca'Foncello; 🇮🇹 Treviso, Italy

McMaster University; 🇨🇦 Hamilton, Canada

Clinica Santa Maria; 🇮🇹 Bari, Apulia, Italy

Victoria Cardiac Arrhythmia Trials Inc - Royal Jubilee; 🇨🇦 Victoria, Canada