N/A
N=26
Magnetic Stimulation to Treat VT Storm
Ventricular Tachycardia
Bottom Line
View on ClinicalTrials.gov: NCT04043312 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Jul 2022
Primary outcome: Primary: Ventricular Tachycardia - Incidence of Ventricular Tachycardia on Inpatient Telemetry Monitoring — 7; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Magstim SuperRapid (Device)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ventricular Tachycardia - Incidence of Ventricular Tachycardia on Inpatient Telemetry Monitoring |
7; 4 | — |
| SECONDARY Cardioversion - Incidence of ICD Therapies or External Defibrillation Following Stimulation on Device Interrogation or Telemetry |
7; 4 | — |
| SECONDARY Number of Patients With Changes in ICD or Pacemaker Lead Impedances |
0; 0 | — |
| SECONDARY Number of Patients With Changes in ICD or Pacemaker Lead Thresholds |
0; 0 | — |
| SECONDARY Number of Patient With Changes in ICD or Pacemaker Lead Sensitivities |
0; 0 | — |
| SECONDARY Local Effect From Stimulation - Patient Reported Local Discomfort on Visual Analog Scale (0-10) |
0; 0 | — |
| SECONDARY Antiarrhythmic Drugs Used Post Stimulation - Incidence of Antiarrhythmic Drug Use Post Stimulation Per Inpatient Medical Record |
2.3; 0.9 | — |
| SECONDARY Number of Patients With Changes in ECG Parameters |
0; 0 | — |
| SECONDARY Number of Patients With Changes in Vital Signs |
0; 0 | — |
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)
Data sourced from ClinicalTrials.gov (NCT04043312). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.