Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-29 @ 6:20 PM
Study NCT ID:
NCT00367757
Status:
COMPLETED
Last Update Posted:
2019-01-30
First Post:
2006-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
STAR-AF:Substrate Versus Trigger Ablation for Reduction of Atrial Fibrillation Trial
Sponsor:
Abbott Medical Devices
Organization:
Study Overview
Official Title:
Open, Prospective, Randomized Trial Comparing Trigger vs Substrate vs Hybrid Approaches for AF Ablation
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: