STAR-VT: Magnetic Stimulation to Treat VT Storm

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT04043312
• Collaborator: (none)
• Enrollment: 26
• Location: 1
• Arms: 2
• Actual Duration (Months): 23.5
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ventricular Tachycardia	Device: Magstim SuperRapid; Device: Magstim SuperRapid	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: A Randomized Controled Trial of Transcutaneous Magnetic Stimulation of the Stellate Ganglion to Treat Ventricular Tachycardia Storm
• Actual Study Start Date: Aug 14, 2019
• Actual Primary Completion Date: Jun 30, 2021
• Actual Study Completion Date: Jul 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: Control Patients will receive one hour of sham stimulation.	Device: Magstim SuperRapid; Sham transcutaneous magnetic stimulation.
Experimental: Active Patients will receive one hour of active magnetic stimulation to the left stellate ganglion.	Device: Magstim SuperRapid; Transcutaneous magnetic stimulation targeting the left stellate ganglion.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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

2. 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

3. 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

4. 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

5. 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.

6. 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

7. 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.

8. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• University of Pennsylvania

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 4, 2022

More Information

Publications

None provided.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT04043312
• Other Study ID Numbers: 833561
• First Posted: Aug 2, 2019
• Last Update Posted: Jul 5, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Tachycardia; Tachycardia, Ventricular

Study Results

Participant Flow

Arm/Group Title	Control	Active
Arm/Group Description	Patients will receive one hour of sham stimulation. Magstim SuperRapid: Sham transcutaneous magnetic stimulation.	Patients will receive one hour of active magnetic stimulation to the left stellate ganglion. Magstim SuperRapid: Transcutaneous magnetic stimulation targeting the left stellate ganglion.
Period Title: Overall Study
STARTED	12	14
COMPLETED	12	14
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Control	Active	Total
Arm/Group Description	Patients will receive one hour of sham stimulation. Magstim SuperRapid: Sham transcutaneous magnetic stimulation.	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 of all reporting groups
Overall Participants	12	14	26
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.7 (10.6)	66.9 (15.2)	64.5 (13.3)
Sex: Female, Male (Count of Participants)
Female	2 16.7%	4 28.6%	6 23.1%
Male	10 83.3%	10 71.4%	20 76.9%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	12 100%	14 100%	26 100%
Episodes of VT (Episodes) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Episodes]	14.8 (11.9)	11.0 (8.7)	12.7 (10.3)
Number of Antiarrhythmic Drugs Failed (Drugs) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Drugs]	2.2 (0.7)	1.9 (0.5)	2.0 (0.6)
Mechanical hemodynamic support (Count of Participants)
Count of Participants [Participants]	6 50%	5 35.7%	11 42.3%

Outcome Measures

1. Primary Outcome

Title	Ventricular Tachycardia - Incidence of Ventricular Tachycardia on Inpatient Telemetry Monitoring
Description	Incidence of ventricular tachycardia on inpatient telemetry monitoring
Time Frame	24-hours following completion of the protocol

Outcome Measure Data

Analysis Population Description

All enrolled patients

Arm/Group Title	Control	Active
Arm/Group Description	Patients will receive one hour of sham stimulation. Magstim SuperRapid: Sham transcutaneous magnetic stimulation.	Patients will receive one hour of active magnetic stimulation to the left stellate ganglion. Magstim SuperRapid: Transcutaneous magnetic stimulation targeting the left stellate ganglion.
Measure Participants	12	14
Count of Participants [Participants]	7 58.3%	4 28.6%

2. Secondary Outcome

Title	Cardioversion - Incidence of ICD Therapies or External Defibrillation Following Stimulation on Device Interrogation or Telemetry
Description	Incidence of ICD or external defibrillation following stimulation on device interrogation or telemetry
Time Frame	48-hours following completion of the protocol

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Number of Patients With Changes in ICD or Pacemaker Lead Impedances
Description	Number of patients with changes in lead impedance (unit: Ohms) on device interrogation
Time Frame	Immediately following completion of the protocol

Outcome Measure Data

Analysis Population Description

All patients with CIED

Arm/Group Title	Control	Active
Arm/Group Description	Patients will receive one hour of sham stimulation. Magstim SuperRapid: Sham transcutaneous magnetic stimulation.	Patients will receive one hour of active magnetic stimulation to the left stellate ganglion. Magstim SuperRapid: Transcutaneous magnetic stimulation targeting the left stellate ganglion.
Measure Participants	6	7
Count of Participants [Participants]	0 0%	0 0%

4. Secondary Outcome

Title	Number of Patients With Changes in ICD or Pacemaker Lead Thresholds
Description	Number of patients with changes in lead thresholds (unit: mV) on device interrogation
Time Frame	Immediately following completion of the protocol

Outcome Measure Data

Analysis Population Description

Patients with CIED

Arm/Group Title	Control	Active
Arm/Group Description	Patients will receive one hour of sham stimulation. Magstim SuperRapid: Sham transcutaneous magnetic stimulation.	Patients will receive one hour of active magnetic stimulation to the left stellate ganglion. Magstim SuperRapid: Transcutaneous magnetic stimulation targeting the left stellate ganglion.
Measure Participants	6	7
Count of Participants [Participants]	0 0%	0 0%

5. Secondary Outcome

Title	Number of Patient With Changes in ICD or Pacemaker Lead Sensitivities
Description	Number of patient with changes in lead sensitivity (unit: mA) on device interrogation
Time Frame	Immediately following completion of the protocol

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Active
Arm/Group Description	Patients will receive one hour of sham stimulation. Magstim SuperRapid: Sham transcutaneous magnetic stimulation.	Patients will receive one hour of active magnetic stimulation to the left stellate ganglion. Magstim SuperRapid: Transcutaneous magnetic stimulation targeting the left stellate ganglion.
Measure Participants	6	7
Count of Participants [Participants]	0 0%	0 0%

6. Secondary Outcome

Title	Local Effect From Stimulation - Patient Reported Local Discomfort on Visual Analog Scale (0-10)
Description	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

Outcome Measure Data

Analysis Population Description

Nonsedated patients

Arm/Group Title	Control	Active
Arm/Group Description	Patients will receive one hour of sham stimulation. Magstim SuperRapid: Sham transcutaneous magnetic stimulation.	Patients will receive one hour of active magnetic stimulation to the left stellate ganglion. Magstim SuperRapid: Transcutaneous magnetic stimulation targeting the left stellate ganglion.
Measure Participants	4	10
Mean (Standard Deviation) [Pain score]	0 (0)	0 (0)

7. Secondary Outcome

Title	Antiarrhythmic Drugs Used Post Stimulation - Incidence of Antiarrhythmic Drug Use Post Stimulation Per Inpatient Medical Record
Description	Incidence of antiarrhythmic drug use post stimulation per inpatient medical record
Time Frame	24 hours following completion of the protocol

Outcome Measure Data

Analysis Population Description

All participants

Arm/Group Title	Control	Active
Arm/Group Description	Patients will receive one hour of sham stimulation. Magstim SuperRapid: Sham transcutaneous magnetic stimulation.	Patients will receive one hour of active magnetic stimulation to the left stellate ganglion. Magstim SuperRapid: Transcutaneous magnetic stimulation targeting the left stellate ganglion.
Measure Participants	12	14
Mean (Standard Deviation) [Agents]	2.3 (0.8)	0.9 (0.8)

8. Secondary Outcome

Title	Number of Patients With Changes in ECG Parameters
Description	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

Outcome Measure Data

Analysis Population Description

All participants

Arm/Group Title	Control	Active
Arm/Group Description	Patients will receive one hour of sham stimulation. Magstim SuperRapid: Sham transcutaneous magnetic stimulation.	Patients will receive one hour of active magnetic stimulation to the left stellate ganglion. Magstim SuperRapid: Transcutaneous magnetic stimulation targeting the left stellate ganglion.
Measure Participants	12	14
Count of Participants [Participants]	0 0%	0 0%

9. Secondary Outcome

Title	Number of Patients With Changes in Vital Signs
Description	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

Outcome Measure Data

Analysis Population Description

All participants

Arm/Group Title	Control	Active
Arm/Group Description	Patients will receive one hour of sham stimulation. Magstim SuperRapid: Sham transcutaneous magnetic stimulation.	Patients will receive one hour of active magnetic stimulation to the left stellate ganglion. Magstim SuperRapid: Transcutaneous magnetic stimulation targeting the left stellate ganglion.
Measure Participants	12	14
Count of Participants [Participants]	0 0%	0 0%

Adverse Events

Time Frame	For 72 hours after enrollment
Arm/Group Title	Control		Active
Arm/Group Description	Patients will receive one hour of sham stimulation. Magstim SuperRapid: Sham transcutaneous magnetic stimulation.		Patients will receive one hour of active magnetic stimulation to the left stellate ganglion. Magstim SuperRapid: Transcutaneous magnetic stimulation targeting the left stellate ganglion.
All Cause Mortality
	Control		Active
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/12 (33.3%)		3/14 (21.4%)
Serious Adverse Events
	Control		Active
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/14 (0%)
Other (Not Including Serious) Adverse Events
	Control		Active
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/14 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.