Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00367757
Status:
COMPLETED
Last Update Posted:
2019-01-30
First Post:
2006-08-22
Brief Title:
STAR-AFSubstrate Versus Trigger Ablation for Reduction of Atrial Fibrillation Trial
Sponsor:
Abbott Medical Devices
Organization:
Abbott Medical Devices
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 andor ECGHolter 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 andor ECGHolter 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:
None
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?:
None