Clinical trial NCT04043312: Magnetic Stimulation to Treat VT Storm
Official title: A Randomized Controled Trial of Transcutaneous Magnetic Stimulation of the Stellate Ganglion to Treat Ventricular Tachycardia Storm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventricular Tachycardia
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2019-08-02
Enrollment: 26
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Ventricular Tachycardia - Incidence of Ventricular Tachycardia on Inpatient Telemetry Monitoring
timeFrame: 24-hours following completion of the protocol
Secondary outcomes:
measure: Cardioversion - Incidence of ICD Therapies or External Defibrillation Following Stimulation on Device Interrogation or Telemetry
timeFrame: 48-hours following completion of the protocol
measure: Number of Patients With Changes in ICD or Pacemaker Lead Impedances
timeFrame: Immediately following completion of the protocol
measure: Number of Patients With Changes in ICD or Pacemaker Lead Thresholds
timeFrame: Immediately following completion of the protocol
measure: Number of Patient With Changes in ICD or Pacemaker Lead Sensitivities
timeFrame: Immediately following completion of the protocol
measure: Local Effect From Stimulation - Patient Reported Local Discomfort on Visual Analog Scale (0-10)
timeFrame: Immediately following completion of the protocol
measure: Antiarrhythmic Drugs Used Post Stimulation - Incidence of Antiarrhythmic Drug Use Post Stimulation Per Inpatient Medical Record
timeFrame: 24 hours following completion of the protocol
measure: Number of Patients With Changes in ECG Parameters
timeFrame: Immediately following completion of the stimulation
measure: Number of Patients With Changes in Vital Signs
timeFrame: Immediately following the completion of the stimulation
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
References:
citation: Markman TM, Pothineni NVK, Zghaib T, Smietana J, McBride D, Amankwah NA, Linn KA, Kumareswaran R, Hyman M, Arkles J, Santangeli P, Schaller RD, Supple GE, Frankel DS, Deo R, Lin D, Riley MP, Epstein AE, Callans DJ, Marchlinski FE, Hamilton R, Nazarian S. Effect of Transcutaneous Magnetic Stimulation in Patients With Ventricular Tachycardia Storm: A Randomized Clinical Trial. JAMA Cardiol. 2022 Apr 1;7(4):445-449. doi: 10.1001/jamacardio.2021.6000.