Ventricular Tachycardia
Conditions
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.
Interventions
DEVICEMagstim SuperRapid
Transcutaneous magnetic stimulation targeting the left stellate ganglion.
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ventricular Tachycardia - Incidence of Ventricular Tachycardia on Inpatient Telemetry Monitoring | 24-hours following completion of the protocol | Incidence of ventricular tachycardia on inpatient telemetry monitoring |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Changes in ICD or Pacemaker Lead Impedances | Immediately following completion of the protocol | Number of patients with changes in lead impedance (unit: Ohms) on device interrogation |
| Number of Patients With Changes in ICD or Pacemaker Lead Thresholds | Immediately following completion of the protocol | Number of patients with changes in lead thresholds (unit: mV) on device interrogation |
| Number of Patient With Changes in ICD or Pacemaker Lead Sensitivities | Immediately following completion of the protocol | Number of patient with changes in lead sensitivity (unit: mA) on device interrogation |
| Cardioversion - Incidence of ICD Therapies or External Defibrillation Following Stimulation on Device Interrogation or Telemetry | 48-hours following completion of the protocol | Incidence of ICD or external defibrillation following stimulation on device interrogation or telemetry |
| Antiarrhythmic Drugs Used Post Stimulation - Incidence of Antiarrhythmic Drug Use Post Stimulation Per Inpatient Medical Record | 24 hours following completion of the protocol | Incidence of antiarrhythmic drug use post stimulation per inpatient medical record |
| Number of Patients With Changes in ECG Parameters | Immediately following completion of the stimulation | Number of patients with any clinical significant change in PR, QRS, or QT interval before and after stimulation. |
| Number of Patients With Changes in Vital Signs | Immediately following the completion of the stimulation | Number of patients with clinical significant change in heart rate or blood pressure during the procedure. |
| Local Effect From Stimulation - Patient Reported Local Discomfort on Visual Analog Scale (0-10) | Immediately following completion of the protocol | Scores on a visual analog scale (0-10) of discomfort - 0= no discomfort, 1 = minimal discomfort, 10 = most severe discomfort imaginable. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Patients will receive one hour of sham stimulation.
Magstim SuperRapid: Sham transcutaneous magnetic stimulation. | 12 |
| Active Patients will receive one hour of active magnetic stimulation to the left stellate ganglion.
Magstim SuperRapid: Transcutaneous magnetic stimulation targeting the left stellate ganglion. | 14 |
| Total | 26 |
Baseline characteristics
| Characteristic | Active | Total | Control |
|---|---|---|---|
| Age, Continuous | 66.9 years STANDARD_DEVIATION 15.2 | 64.5 years STANDARD_DEVIATION 13.3 | 61.7 years STANDARD_DEVIATION 10.6 |
| Episodes of VT | 11.0 Episodes STANDARD_DEVIATION 8.7 | 12.7 Episodes STANDARD_DEVIATION 10.3 | 14.8 Episodes STANDARD_DEVIATION 11.9 |
| Mechanical hemodynamic support | 5 Participants | 11 Participants | 6 Participants |
| Number of Antiarrhythmic Drugs Failed | 1.9 Drugs STANDARD_DEVIATION 0.5 | 2.0 Drugs STANDARD_DEVIATION 0.6 | 2.2 Drugs STANDARD_DEVIATION 0.7 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 14 participants | 26 participants | 12 participants |
| Sex: Female, Male Female | 4 Participants | 6 Participants | 2 Participants |
| Sex: Female, Male Male | 10 Participants | 20 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 12 | 3 / 14 |
| other Total, other adverse events | 0 / 12 | 0 / 14 |
| serious Total, serious adverse events | 0 / 12 | 0 / 14 |
Outcome results
Primary
Ventricular Tachycardia - Incidence of Ventricular Tachycardia on Inpatient Telemetry Monitoring
Incidence of ventricular tachycardia on inpatient telemetry monitoring
Time frame: 24-hours following completion of the protocol
Population: All enrolled patients
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Ventricular Tachycardia - Incidence of Ventricular Tachycardia on Inpatient Telemetry Monitoring | 7 Participants |
| Active | Ventricular Tachycardia - Incidence of Ventricular Tachycardia on Inpatient Telemetry Monitoring | 4 Participants |
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
Time frame: 24 hours following completion of the protocol
Population: All participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Antiarrhythmic Drugs Used Post Stimulation - Incidence of Antiarrhythmic Drug Use Post Stimulation Per Inpatient Medical Record | 2.3 Agents | Standard Deviation 0.8 |
| Active | Antiarrhythmic Drugs Used Post Stimulation - Incidence of Antiarrhythmic Drug Use Post Stimulation Per Inpatient Medical Record | 0.9 Agents | Standard Deviation 0.8 |
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
Time frame: 48-hours following completion of the protocol
Population: Entire population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Cardioversion - Incidence of ICD Therapies or External Defibrillation Following Stimulation on Device Interrogation or Telemetry | 7 Participants |
| Active | Cardioversion - Incidence of ICD Therapies or External Defibrillation Following Stimulation on Device Interrogation or Telemetry | 4 Participants |
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.
Time frame: Immediately following completion of the protocol
Population: Nonsedated patients
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Local Effect From Stimulation - Patient Reported Local Discomfort on Visual Analog Scale (0-10) | 0 Pain score | Standard Deviation 0 |
| Active | Local Effect From Stimulation - Patient Reported Local Discomfort on Visual Analog Scale (0-10) | 0 Pain score | Standard Deviation 0 |
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.
Time frame: Immediately following completion of the stimulation
Population: All participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Number of Patients With Changes in ECG Parameters | 0 Participants |
| Active | Number of Patients With Changes in ECG Parameters | 0 Participants |
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
Time frame: Immediately following completion of the protocol
Population: All patients with CIED
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Number of Patients With Changes in ICD or Pacemaker Lead Impedances | 0 Participants |
| Active | Number of Patients With Changes in ICD or Pacemaker Lead Impedances | 0 Participants |
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
Time frame: Immediately following completion of the protocol
Population: Patients with CIED
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Number of Patients With Changes in ICD or Pacemaker Lead Thresholds | 0 Participants |
| Active | Number of Patients With Changes in ICD or Pacemaker Lead Thresholds | 0 Participants |
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.
Time frame: Immediately following the completion of the stimulation
Population: All participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Number of Patients With Changes in Vital Signs | 0 Participants |
| Active | Number of Patients With Changes in Vital Signs | 0 Participants |
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
Time frame: Immediately following completion of the protocol
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Number of Patient With Changes in ICD or Pacemaker Lead Sensitivities | 0 Participants |
| Active | Number of Patient With Changes in ICD or Pacemaker Lead Sensitivities | 0 Participants |