Ignite Creation Date:
2024-05-06 @ 6:54 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05828667
Status:
RECRUITING
Last Update Posted:
2023-10-30
First Post:
2023-03-06
Brief Title:
The STandard Versus ImAging SuBstrate Aided Ablation in Severe Left VEntricular Dysfunction VT
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
The STandard Versus ImAging SuBstrate Aided Ablation in Severe Left VEntricular
Status:
RECRUITING
Status Verified Date:
2023-10
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:
STABLE-VT
Brief Summary:
The STABLE-VT trial aims to determine the safety profile and clinical efficacy of a modified approach to ventricular tachycardia VT ablation that integrates myocardial scar as visualized on cardiac magnetic resonance c-MRI or CT into electroanatomical mapping EAM for VT ablation
Detailed Description:
The STABLE-VT trial aims to integrate myocardial scar as visualized on cardiac magnetic resonance c-MRI or CT into electroanatomical mapping EAM for VT ablation Particularly we will compare the procedural safety and acute and long-term clinical efficacy of this imaging-aided VT ablation protocol to standard of care
Our hypothesis is that patients with ventricular tachycardia VT and severe LV dysfunction randomized to this imaging-aided protocol will have shorter procedure duration improved procedural hemodynamic stability fewer acute major adverse cardiovascular events MACE less need for mechanical support comparable freedom from VT at noninvasive programmed stimulation NIPS sub-acutely after the procedure and at two-year follow-up compared to standard ablation approach Herein our outcomes of interest will be captured during the two years following as part of regular standard of care follow-ups
Our hypothesis is that patients with ventricular tachycardia VT and severe LV dysfunction randomized to this imaging-aided protocol will have shorter procedure duration improved procedural hemodynamic stability fewer acute major adverse cardiovascular events MACE less need for mechanical support comparable freedom from VT at noninvasive programmed stimulation NIPS sub-acutely after the procedure and at two-year follow-up compared to standard ablation approach Herein our outcomes of interest will be captured during the two years following as part of regular standard of care follow-ups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None