Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
Study NCT ID:
NCT04043312
Status:
COMPLETED
Last Update Posted:
2022-11-08
First Post:
2019-07-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Magnetic Stimulation to Treat VT Storm
Sponsor:
University of Pennsylvania
Organization:
Study Overview
Official Title:
A Randomized Controled Trial of Transcutaneous Magnetic Stimulation of the Stellate Ganglion to Treat Ventricular Tachycardia Storm
Status:
COMPLETED
Status Verified Date:
2022-10
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:
STAR-VT
Brief Summary:
Ventricular Tachycardia storm is a medical emergency characterized by three or more episodes of ventricular arrhythmia within 24 hours and associated with a significantly increased mortality and massive health resource utilization. Several therapies are utilized including sympathetic blockade (through deep sedation and beta blockers), antiarrhythmic drugs, implantable cardioverter defibrillator (ICD) reprograming where applicable, and catheter ablation. Despite standard intervention, mortality rates remain high and additional therapeutic options are actively being investigated.
The overall objective of this proposal is to investigate whether transcutaneous magnetic stimulation designed to inhibit the left stellate ganglion can be used in this population. This is a single-center, randomized, sham-controlled trial to assess the efficacy of transcutaneous magnetic stimulation of the left stellate ganglion to treat patients with ventricular tachycardia storm.
The overall objective of this proposal is to investigate whether transcutaneous magnetic stimulation designed to inhibit the left stellate ganglion can be used in this population. This is a single-center, randomized, sham-controlled trial to assess the efficacy of transcutaneous magnetic stimulation of the left stellate ganglion to treat patients with ventricular tachycardia storm.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: