Magnetic Stimulation to Treat VT Storm (STAR-VT)
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|ClinicalTrials.gov Identifier: NCT04043312|
Recruitment Status : Recruiting
First Posted : August 2, 2019
Last Update Posted : September 19, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Ventricular Tachycardia||Device: Magstim SuperRapid||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||A Randomized Controled Trial of Transcutaneous Magnetic Stimulation of the Stellate Ganglion to Treat Ventricular Tachycardia Storm|
|Actual Study Start Date :||August 14, 2019|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||August 2020|
Sham Comparator: Control
Patients will receive one hour of sham stimulation.
Device: Magstim SuperRapid
Sham transcutaneous magnetic stimulation.
Patients will receive one hour of active magnetic stimulation to the left stellate ganglion.
Device: Magstim SuperRapid
Transcutaneous magnetic stimulation targeting the left stellate ganglion.
- Ventricular Tachycardia - Incidence of ventricular tachycardia on inpatient telemetry monitoring [ Time Frame: 24-hours following completion of the protocol ]Incidence of ventricular tachycardia on inpatient telemetry monitoring
- Cardioversion - Incidence of ICD or external defibrillation following stimulation on device interrogation or telemetry [ Time Frame: 48-hours following completion of the protocol ]Incidence of ICD or external defibrillation following stimulation on device interrogation or telemetry
- Changes in ICD or pacemaker lead impedances [ Time Frame: Immediately following completion of the protocol ]Change in lead impedance (unit: Ohms) on device interrogation
- Changes in ICD or pacemaker lead thresholds [ Time Frame: Immediately following completion of the protocol ]Change in lead thresholds (unit: mV) on device interrogation
- Changes in ICD or pacemaker lead sensitivities [ Time Frame: Immediately following completion of the protocol ]Change in lead sensitivity (unit: mA) on device interrogation
- Local effect from stimulation - Incidence of local skin irritation or patient reported local discomfort on visual analog scale (1-10) [ Time Frame: Immediately following completion of the protocol ]Incidence of local skin irritation or patient reported local discomfort on visual analog scale (1-10)
- Antiarrhythmic drugs used post stimulation - Incidence of antiarrhythmic drug use post stimulation per inpatient medical record [ Time Frame: 72 hours following completion of the protocol ]Incidence of antiarrhythmic drug use post stimulation per inpatient medical record
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04043312
|Contact: Timothy Markman, MDemail@example.com|
|United States, Pennsylvania|
|Hospital of the University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Timothy Markman, MD|