Ignite Creation Date:
2024-05-06 @ 2:50 AM
Last Modification Date:
2024-10-26 @ 11:23 AM
Study NCT ID:
NCT02130765
Status:
TERMINATED
Last Update Posted:
2019-02-12
First Post:
2014-04-28
Brief Title:
Substrate Targeted Ablation Using the FlexAbility Ablation Catheter System for the Reduction of Ventricular Tachycardia
Sponsor:
Abbott Medical Devices
Organization:
Abbott Medical Devices
Study Overview
Official Title:
Substrate Targeted Ablation Using the FlexAbility Ablation Catheter System for the Reduction of Ventricular Tachycardia STAR-VT - G130132
Status:
TERMINATED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated due to low enrollment rate
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STAR-VT
Brief Summary:
To demonstrate that scar-based ventricular tachycardia VT ablation using the FlexAbility ablation catheter system results in a superior clinical outcome compared to routine drug therapy in subjects with documented Monomorphic Ventricular Tachycardia MMVT both ischemic and non-ischemic while maintaining an acceptable safety profile
Detailed Description:
Approximately 50 centers in the United States US will participate in the study Additional centers outside the US may be considered as necessary The anticipated enrollment duration is 48-60 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None