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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00367757
• Other study ID #: AF06002AF
• Status: Completed
• Phase: N/A
• Start date: August 2006
• Est. completion date: July 2009

Study information

• Verified date: January 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Ablate AF triggers via PVI
Trigger-based ablation guided by pulmonary vein antrum isolation
• Substrate via CFAEs
Substrate-based ablation using an approach targeting CFAEs
• Combined approach for AF ablation
Combined trigger and substrate based approach

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton
Canada	Montreal Heaert Institute	Montreal	Quebec
Canada	Southlake Regional Health Centre	Newmarket	Ontario
Canada	Victoria Cardiac Arrhythmia Trials Inc - Royal Jubilee	Victoria
Italy	Clinica Santa Maria	Bari	Apulia
Italy	Ospedale Regionale Ca'Foncello	Treviso
Norway	Haukeland Universitetssykehus	Bergen	Haukeland
Spain	Hospital General Universitario Gregorio Marañón	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

Canada,  Italy,  Norway,  Spain, 

Outcome

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