Magnetic Stimulation to Treat VT Storm

Ventricular Tachycardia Clinical Trial

— STAR-VT  

Official title:

A Randomized Controled Trial of Transcutaneous Magnetic Stimulation of the Stellate Ganglion to Treat Ventricular Tachycardia Storm

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04043312
• Other study ID #: 833561
• Status: Completed
• Phase: N/A
• Start date: August 14, 2019
• Est. completion date: July 30, 2021

Study information

• Verified date: October 2022
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: July 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• = 3 episodes of VT in 24 hours

Exclusion Criteria:

• Pregnancy

• Implanted ventricular assist device

• Metal implanted in head or neck (except the mouth)

• Implanted medication pumps

• Cochlear implant

• Implanted brain stimulator

• Ocular implant

• History of active malignancy in region of stimulation (neck)

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

Device:
• Magstim SuperRapid
Transcutaneous magnetic stimulation targeting the left stellate ganglion.
• Magstim SuperRapid
Sham transcutaneous magnetic stimulation.

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventricular Tachycardia - Incidence of Ventricular Tachycardia on Inpatient Telemetry Monitoring	Incidence of ventricular tachycardia on inpatient telemetry monitoring	24-hours following completion of the protocol
Secondary	Cardioversion - Incidence of ICD Therapies or External Defibrillation Following Stimulation on Device Interrogation or Telemetry	Incidence of ICD or external defibrillation following stimulation on device interrogation or telemetry	48-hours following completion of the protocol
Secondary	Number of Patients With Changes in ICD or Pacemaker Lead Impedances	Number of patients with changes in lead impedance (unit: Ohms) on device interrogation	Immediately following completion of the protocol
Secondary	Number of Patients With Changes in ICD or Pacemaker Lead Thresholds	Number of patients with changes in lead thresholds (unit: mV) on device interrogation	Immediately following completion of the protocol
Secondary	Number of Patient With Changes in ICD or Pacemaker Lead Sensitivities	Number of patient with changes in lead sensitivity (unit: mA) on device interrogation	Immediately following completion of the protocol
Secondary	Local Effect From Stimulation - Patient Reported Local Discomfort on Visual Analog Scale (0-10)	Scores on a visual analog scale (0-10) of discomfort - 0= no discomfort, 1 = minimal discomfort, 10 = most severe discomfort imaginable.	Immediately following completion of the protocol
Secondary	Antiarrhythmic Drugs Used Post Stimulation - Incidence of Antiarrhythmic Drug Use Post Stimulation Per Inpatient Medical Record	Incidence of antiarrhythmic drug use post stimulation per inpatient medical record	24 hours following completion of the protocol
Secondary	Number of Patients With Changes in ECG Parameters	Number of patients with any clinical significant change in PR, QRS, or QT interval before and after stimulation.	Immediately following completion of the stimulation
Secondary	Number of Patients With Changes in Vital Signs	Number of patients with clinical significant change in heart rate or blood pressure during the procedure.	Immediately following the completion of the stimulation