Clinical trial NCT00367757: STAR-AF:Substrate Versus Trigger Ablation for Reduction of Atrial Fibrillation Trial
Official title: Open, Prospective, Randomized Trial Comparing Trigger vs Substrate vs Hybrid Approaches for AF Ablation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: paroxysmal atrial fibrillation
persistent atrial fibrillation
high burden of atrial fibrillation
atrial fibrillation ablation
Pulmonary vein isolation
AF trigger
complex fractionated electrograms
CFE
CFAE
complex fractionated atrial electrograms
refractory antiarrhythmic medication
PVAI
Ensite NavX
NavX
CoolPath catheter
irrigated ablation catheter
high burden of paroxysmal or persistent atrial fibrillation
candidates for AF ablation
symptomatic AF
AF is refractory to at least one antiarrhythmic medication
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2006-08-23
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Freedom from atrial fibrillation at 3 months post-first ablation procedure off antiarrhythmic medications.
timeFrame: 3 months
measure: Freedom from atrial fibrillation at 6 and 12 months post-first ablation procedure off antiarrhythmic medications.
timeFrame: 12 months
Secondary outcomes:
measure: Freedom from atrial fibrillation on or off antiarrhythmic medications at 3, 6 and 12 months post-first ablation procedure.
timeFrame: 12 months
measure: Freedom from atrial fibrillation and other atrial arrhythmias at 3, 6 and 12 months post-first ablation procedure.
timeFrame: 12 months
measure: Incidence of peri-procedural complications including stroke, PV stenosis, cardiac perforation, esophageal injury, and death.
timeFrame: 12 months
measure: Procedure duration at ablation.
timeFrame: At intervention
measure: Fluoroscopy time at ablation.
timeFrame: At intervention
measure: Quality of life measurements (SF-36) at baseline, 3, 6 and 12 months post-first procedure.
timeFrame: 12 months
Other outcomes:
Locations:
city: Newmarket
country: Canada
facility: Southlake Regional Health Centre
state: Ontario
city: Montreal
country: Canada
facility: Montreal Heaert Institute
state: Quebec
city: Hamilton
country: Canada
facility: McMaster University
city: Victoria
country: Canada
facility: Victoria Cardiac Arrhythmia Trials Inc - Royal Jubilee
city: Bari
country: Italy
facility: Clinica Santa Maria
state: Apulia
city: Treviso
country: Italy
facility: Ospedale Regionale Ca'Foncello
city: Bergen
country: Norway
facility: Haukeland Universitetssykehus
state: Haukeland
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
Study officials:
affiliation: Southlake Regional health Center
name: Atul Verma, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Verma A, Mantovan R, Macle L, De Martino G, Chen J, Morillo CA, Novak P, Calzolari V, Guerra PG, Nair G, Torrecilla EG, Khaykin Y. Substrate and Trigger Ablation for Reduction of Atrial Fibrillation (STAR AF): a randomized, multicentre, international trial. Eur Heart J. 2010 Jun;31(11):1344-56. doi: 10.1093/eurheartj/ehq041. Epub 2010 Mar 9.