Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Sham Comparator | Patients will receive one hour of sham stimulation. |
|
| Active | Experimental | Patients will receive one hour of active magnetic stimulation to the left stellate ganglion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magstim SuperRapid | Device | Transcutaneous magnetic stimulation targeting the left stellate ganglion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Number of Patients With Changes in ICD or Pacemaker Lead Impedances |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35171197 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Control | Patients will receive one hour of sham stimulation. Magstim SuperRapid: Sham transcutaneous magnetic stimulation. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Control | Patients will receive one hour of sham stimulation. Magstim SuperRapid: Sham transcutaneous magnetic stimulation. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ventricular Tachycardia - Incidence of Ventricular Tachycardia on Inpatient Telemetry Monitoring | Incidence of ventricular tachycardia on inpatient telemetry monitoring | All enrolled patients | Posted | Count of Participants | Participants | 24-hours following completion of the protocol |
|
For 72 hours after enrollment
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Patients will receive one hour of sham stimulation. Magstim SuperRapid: Sham transcutaneous magnetic stimulation. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Timothy Markman | Hospital of the University of Pennsylvania | 267-593-0103 | timothy.markman@uphs.upenn.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 4, 2022 | Jun 4, 2022 | Prot_SAP_002.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Magstim SuperRapid | Device | Sham transcutaneous magnetic stimulation. |
|
Number of patients with changes in lead impedance (unit: Ohms) on device interrogation |
| Immediately following completion of the protocol |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Episodes of VT | Mean | Standard Deviation | Episodes |
|
| Number of Antiarrhythmic Drugs Failed | Mean | Standard Deviation | Drugs |
|
| Mechanical hemodynamic support | Count of Participants | Participants |
|
|
|
| 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 | Entire population | Posted | Count of Participants | Participants | 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 | All patients with CIED | Posted | Count of Participants | Participants | 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 | Patients with CIED | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | 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. | Nonsedated patients | Posted | Mean | Standard Deviation | Pain score | 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 | All participants | Posted | Mean | Standard Deviation | Agents | 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. | All participants | Posted | Count of Participants | Participants | 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. | All participants | Posted | Count of Participants | Participants | Immediately following the completion of the stimulation |
|
|
|
| 4 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | 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. | 3 | 14 | 0 | 14 | 0 | 14 |
Not provided
Not provided
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |