Ventricular TachycardiaSTAR-VTNCT04043312
Magnetic Stimulation to Treat VT Storm
A study testing Magstim SuperRapid in people with Ventricular Tachycardia, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Ventricular Tachycardia
- What is being tested?
- Magstim SuperRapid
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2019to 30 Jul 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 3 episodes of VT in 24 hours
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Randomized Controled Trial of Transcutaneous Magnetic Stimulation of the Stellate Ganglion to Treat Ventricular Tachycardia Storm
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.
- Conditions
- Ventricular Tachycardia
- Being tested
- Magstim SuperRapid
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magstim SuperRapidDevice
Transcutaneous magnetic stimulation targeting the left stellate ganglion.
Magstim SuperRapidDevice
Sham transcutaneous magnetic stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Control | Sham comparator | Patients will receive one hour of sham stimulation. Receives: Device: Magstim SuperRapid |
| Active | Experimental | Patients will receive one hour of active magnetic stimulation to the left stellate ganglion. Receives: Device: Magstim SuperRapid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventricular Tachycardia - Incidence of Ventricular Tachycardia on Inpatient Telemetry Monitoring
Incidence of ventricular tachycardia on inpatient telemetry monitoring
Measured: 24-hours following completion of the protocol
Secondary outcomes (8)
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
Measured: 48-hours following completion of the protocol
Number of Patients With Changes in ICD or Pacemaker Lead Impedances
Number of patients with changes in lead impedance (unit: Ohms) on device interrogation
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Immediately following the completion of the stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start14 Aug 2019
- Primary completion30 Jun 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04043312
- Sponsor's protocol ID
- 833561
- Acronym
- STAR-VT
- Status last verified
- Oct 2022
- First submitted
- 25 Jul 2019
- Last updated
- 8 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 35171197
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controled Trial of Transcutaneous Magnetic Stimulation of the Stellate Ganglion to Treat Ventricular Tachycardia Storm
- ClinicalTrials.gov ID
- NCT04043312
- Acronym / sponsor ID
- STAR-VT / 833561
- Conditions
- Ventricular Tachycardia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 14 Aug 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 2 Aug 2019 (actual)
- Results
- Posted 5 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Device: Magstim SuperRapidPatients will receive one hour of sham stimulation. |
| Active | Experimental | Device: Magstim SuperRapidPatients will receive one hour of active magnetic stimulation to the left stellate ganglion. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ≥ 3 episodes of VT in 24 hours
Key exclusion criteria (8 listed)
- Pregnancy
- Implanted ventricular assist device
- Metal implanted in head or neck (except the mouth)
- Implanted medication pumps
- Cochlear implant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magstim SuperRapidTranscutaneous magnetic stimulation targeting the left stellate ganglion. | Device | Active |
| Magstim SuperRapidSham transcutaneous magnetic stimulation. | Device | Control |
Primary outcome
Ventricular Tachycardia - Incidence of Ventricular Tachycardia on Inpatient Telemetry Monitoring
Time frame: 24-hours following completion of the protocol
Incidence of ventricular tachycardia on inpatient telemetry monitoring
8 secondary outcomes
Cardioversion - Incidence of ICD Therapies or External Defibrillation Following Stimulation on Device Interrogation or Telemetry
Time frame: 48-hours following completion of the protocol
Number of Patients With Changes in ICD or Pacemaker Lead Impedances
Time frame: Immediately following completion of the protocol
Number of Patients With Changes in ICD or Pacemaker Lead Thresholds
Time frame: Immediately following completion of the protocol
Number of Patient With Changes in ICD or Pacemaker Lead Sensitivities
Time frame: Immediately following completion of the protocol
Local Effect From Stimulation - Patient Reported Local Discomfort on Visual Analog Scale (0-10)
Time frame: Immediately following completion of the protocol
Antiarrhythmic Drugs Used Post Stimulation - Incidence of Antiarrhythmic Drug Use Post Stimulation Per Inpatient Medical Record
Time frame: 24 hours following completion of the protocol
Number of Patients With Changes in ECG Parameters
Time frame: Immediately following completion of the stimulation
Number of Patients With Changes in Vital Signs
Time frame: Immediately following the completion of the stimulation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35171197Markman 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.
- Individual participant dataSharing planned: No
Related trials for Ventricular Tachycardia
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Assessment of Combined CCM and ICD Device in HFrEF
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A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
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Genetic Markers of Cardiovascular Disease in Epilepsy
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Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)
Tachycardia, Ventricular
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magstim SuperRapid in people with Ventricular Tachycardia, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventricular Tachycardia - Incidence of Ventricular Tachycardia on Inpatient Telemetry Monitoring (time frame: 24-hours following completion of the protocol). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04043312, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.