Trial Outcomes & Findings for Magnetic Stimulation to Treat VT Storm (NCT NCT04043312)

Results Overview

Incidence of ventricular tachycardia on inpatient telemetry monitoring

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

26 participants

Primary outcome timeframe

24-hours following completion of the protocol

Results posted on

2022-11-08

Participant Flow

Participant milestones

Participant milestones
Measure	Control Patients will receive one hour of sham stimulation. Magstim SuperRapid: Sham transcutaneous magnetic stimulation.	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.
Overall Study STARTED	12	14
Overall Study COMPLETED	12	14
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control n=12 Participants Patients will receive one hour of sham stimulation. Magstim SuperRapid: Sham transcutaneous magnetic stimulation.	Active n=14 Participants Patients will receive one hour of active magnetic stimulation to the left stellate ganglion. Magstim SuperRapid: Transcutaneous magnetic stimulation targeting the left stellate ganglion.	Total n=26 Participants Total of all reporting groups
Age, Continuous	61.7 years STANDARD_DEVIATION 10.6 • n=12 Participants	66.9 years STANDARD_DEVIATION 15.2 • n=14 Participants	64.5 years STANDARD_DEVIATION 13.3 • n=26 Participants
Sex: Female, Male Female	2 Participants n=12 Participants	4 Participants n=14 Participants	6 Participants n=26 Participants
Sex: Female, Male Male	10 Participants n=12 Participants	10 Participants n=14 Participants	20 Participants n=26 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	12 participants n=12 Participants	14 participants n=14 Participants	26 participants n=26 Participants
Episodes of VT	14.8 Episodes STANDARD_DEVIATION 11.9 • n=12 Participants	11.0 Episodes STANDARD_DEVIATION 8.7 • n=14 Participants	12.7 Episodes STANDARD_DEVIATION 10.3 • n=26 Participants
Number of Antiarrhythmic Drugs Failed	2.2 Drugs STANDARD_DEVIATION 0.7 • n=12 Participants	1.9 Drugs STANDARD_DEVIATION 0.5 • n=14 Participants	2.0 Drugs STANDARD_DEVIATION 0.6 • n=26 Participants
Mechanical hemodynamic support	6 Participants n=12 Participants	5 Participants n=14 Participants	11 Participants n=26 Participants

PRIMARY outcome

Timeframe: 24-hours following completion of the protocol

Population: All enrolled patients

Incidence of ventricular tachycardia on inpatient telemetry monitoring

Outcome measures

Outcome measures
Measure	Control n=12 Participants Patients will receive one hour of sham stimulation. Magstim SuperRapid: Sham transcutaneous magnetic stimulation.	Active n=14 Participants Patients will receive one hour of active magnetic stimulation to the left stellate ganglion. Magstim SuperRapid: Transcutaneous magnetic stimulation targeting the left stellate ganglion.
Ventricular Tachycardia - Incidence of Ventricular Tachycardia on Inpatient Telemetry Monitoring	7 Participants	4 Participants

SECONDARY outcome

Timeframe: 48-hours following completion of the protocol

Population: Entire population

Incidence of ICD or external defibrillation following stimulation on device interrogation or telemetry

Outcome measures

Outcome measures
Measure	Control n=12 Participants Patients will receive one hour of sham stimulation. Magstim SuperRapid: Sham transcutaneous magnetic stimulation.	Active n=14 Participants Patients will receive one hour of active magnetic stimulation to the left stellate ganglion. Magstim SuperRapid: Transcutaneous magnetic stimulation targeting the left stellate ganglion.
Cardioversion - Incidence of ICD Therapies or External Defibrillation Following Stimulation on Device Interrogation or Telemetry	7 Participants	4 Participants

SECONDARY outcome

Timeframe: Immediately following completion of the protocol

Population: All patients with CIED

Number of patients with changes in lead impedance (unit: Ohms) on device interrogation

Outcome measures

Outcome measures
Measure	Control n=6 Participants Patients will receive one hour of sham stimulation. Magstim SuperRapid: Sham transcutaneous magnetic stimulation.	Active n=7 Participants Patients will receive one hour of active magnetic stimulation to the left stellate ganglion. Magstim SuperRapid: Transcutaneous magnetic stimulation targeting the left stellate ganglion.
Number of Patients With Changes in ICD or Pacemaker Lead Impedances	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Immediately following completion of the protocol

Population: Patients with CIED

Number of patients with changes in lead thresholds (unit: mV) on device interrogation

Outcome measures

Outcome measures
Measure	Control n=6 Participants Patients will receive one hour of sham stimulation. Magstim SuperRapid: Sham transcutaneous magnetic stimulation.	Active n=7 Participants Patients will receive one hour of active magnetic stimulation to the left stellate ganglion. Magstim SuperRapid: Transcutaneous magnetic stimulation targeting the left stellate ganglion.
Number of Patients With Changes in ICD or Pacemaker Lead Thresholds	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Immediately following completion of the protocol

Number of patient with changes in lead sensitivity (unit: mA) on device interrogation

Outcome measures

Outcome measures
Measure	Control n=6 Participants Patients will receive one hour of sham stimulation. Magstim SuperRapid: Sham transcutaneous magnetic stimulation.	Active n=7 Participants Patients will receive one hour of active magnetic stimulation to the left stellate ganglion. Magstim SuperRapid: Transcutaneous magnetic stimulation targeting the left stellate ganglion.
Number of Patient With Changes in ICD or Pacemaker Lead Sensitivities	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Immediately following completion of the protocol

Population: Nonsedated patients

Scores on a visual analog scale (0-10) of discomfort - 0= no discomfort, 1 = minimal discomfort, 10 = most severe discomfort imaginable.

Outcome measures

Outcome measures
Measure	Control n=4 Participants Patients will receive one hour of sham stimulation. Magstim SuperRapid: Sham transcutaneous magnetic stimulation.	Active n=10 Participants Patients will receive one hour of active magnetic stimulation to the left stellate ganglion. Magstim SuperRapid: Transcutaneous magnetic stimulation targeting the left stellate ganglion.
Local Effect From Stimulation - Patient Reported Local Discomfort on Visual Analog Scale (0-10)	0 Pain score Standard Deviation 0	0 Pain score Standard Deviation 0

SECONDARY outcome

Timeframe: 24 hours following completion of the protocol

Population: All participants

Incidence of antiarrhythmic drug use post stimulation per inpatient medical record

Outcome measures

Outcome measures
Measure	Control n=12 Participants Patients will receive one hour of sham stimulation. Magstim SuperRapid: Sham transcutaneous magnetic stimulation.	Active n=14 Participants Patients will receive one hour of active magnetic stimulation to the left stellate ganglion. Magstim SuperRapid: Transcutaneous magnetic stimulation targeting the left stellate ganglion.
Antiarrhythmic Drugs Used Post Stimulation - Incidence of Antiarrhythmic Drug Use Post Stimulation Per Inpatient Medical Record	2.3 Agents Standard Deviation 0.8	0.9 Agents Standard Deviation 0.8

SECONDARY outcome

Timeframe: Immediately following completion of the stimulation

Population: All participants

Number of patients with any clinical significant change in PR, QRS, or QT interval before and after stimulation.

Outcome measures

Outcome measures
Measure	Control n=12 Participants Patients will receive one hour of sham stimulation. Magstim SuperRapid: Sham transcutaneous magnetic stimulation.	Active n=14 Participants Patients will receive one hour of active magnetic stimulation to the left stellate ganglion. Magstim SuperRapid: Transcutaneous magnetic stimulation targeting the left stellate ganglion.
Number of Patients With Changes in ECG Parameters	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Immediately following the completion of the stimulation

Population: All participants

Number of patients with clinical significant change in heart rate or blood pressure during the procedure.

Outcome measures

Outcome measures
Measure	Control n=12 Participants Patients will receive one hour of sham stimulation. Magstim SuperRapid: Sham transcutaneous magnetic stimulation.	Active n=14 Participants Patients will receive one hour of active magnetic stimulation to the left stellate ganglion. Magstim SuperRapid: Transcutaneous magnetic stimulation targeting the left stellate ganglion.
Number of Patients With Changes in Vital Signs	0 Participants	0 Participants

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 4 deaths

Active

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Timothy Markman

Hospital of the University of Pennsylvania

Phone: 267-593-0103

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place