Ventricular TachycardiaNCT05599022
Randomized Assessment of TcMS for VT Storm
A study testing Magnetic Stimulation in people with Ventricular Tachycardia, run by University of Pennsylvania at 1 site in United States.
Trial summary
Three-arm randomized clinical trial comparing two strategies of TcMS to sham stimulation in patients with VT storm. The hypothesis of the study is that TcMS will reduce the burden of VT in the 24 hours after randomization compared to sham stimulation and that TcMS with theta burst stimulation (TBS) will be more… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia
- What is being tested?
- Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2023to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥3 episodes of sustained VT or appropriate ICD therapies within 24 hours despite the use of at least one antiarrhythmic drug
Who cannot join
- Plan for catheter ablation of VT in the next 24 hours
- Pregnancy
- Contraindication to TcMS (i.e. implantable ventricular assist device, metal implanted in the head or neck [except the mouth], implanted medication pumps, cochlear implant, implanted brain stimulator, ocular implant, history of malignancy in the neck)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Timothy Markman, MD
About this study
Official title: Randomized Assessment of the Efficacy of Transcutaneous Magnetic Stimulation in Patients With Ventricular Tachycardia Storm
Three-arm randomized clinical trial comparing two strategies of TcMS to sham stimulation in patients with VT storm. The hypothesis of the study is that TcMS will reduce the burden of VT in the 24 hours after randomization compared to sham stimulation and that TcMS with theta burst stimulation (TBS) will be more effective at reducing VT burden than low frequency TcMS.
- Conditions
- Ventricular Tachycardia
- Being tested
- Magnetic Stimulation
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic StimulationDevice
Transcutaneous Magnetic Stimulation
| Study group | Role | What they receive |
|---|---|---|
| Sham Stimulation | Placebo comparator | With the coil directed away from the patient, 600 pulses of TcMS will be delivered at minimal energy output. Receives: Device: Magnetic Stimulation |
| Low Frequency TcMS | Active comparator | With the coil directed at the stellate ganglion, 60 minutes of 1Hz stimulation will be delivered targeting the stellate ganglion. Receives: Device: Magnetic Stimulation |
| Theta Burst Stimulation TcMS | Active comparator | With the coil directed at the stellate ganglion, 600 pulses of continuous theta burst stimulation will be delivered targeting the stellate ganglion. Receives: Device: Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
VT Burden (24 hours)
Number of episodes of sustained ventricular tachycardia
Measured: 24 hours after randomization
Secondary outcomes (8)
VT burden (72 hours)
Number of episodes of sustained ventricular tachycardia
Measured: 72 hours after randomization
Freedom from VT
Freedom from sustained VT
Measured: 24 hours after randomization
Blood Pressure
Change in mean arterial blood pressure
Measured: Immediately before and after stimulation
Heart Rate
Change in heart rate
Measured: Immediately before and after stimulation
Pain
Pain at site of stimulation (0-10 scale)
Measured: Immediately after stimulation
Lead sensing
Change in implantable device lead sensing
Measured: Immediately before and after stimulation
Lead threshold
Change in implantable device lead pacing threshold
Measured: Immediately before and after stimulation
Lead impedance
Change in implantable device lead pacing impedance
Measured: Immediately before and after stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start22 May 2023
- Primary completionJul 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05599022
- Sponsor's protocol ID
- 852176
- Status last verified
- Apr 2026
- First submitted
- 24 Oct 2022
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Assessment of the Efficacy of Transcutaneous Magnetic Stimulation in Patients With Ventricular Tachycardia Storm
- ClinicalTrials.gov ID
- NCT05599022
- Acronym / sponsor ID
- 852176
- Conditions
- Ventricular Tachycardia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 22 May 2023 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 31 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Three-arm randomized clinical trial comparing two strategies of TcMS to sham stimulation in patients with VT storm. The hypothesis of the study is that TcMS will reduce the burden of VT in the 24 hours after randomization compared to sham stimulation and that TcMS with theta burst stimulation (TBS) will be more effective at reducing VT burden than low frequency TcMS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sham Stimulation | Placebo comparator | Device: Magnetic StimulationWith the coil directed away from the patient, 600 pulses of TcMS will be delivered at minimal energy output. |
| Low Frequency TcMS | Active comparator | Device: Magnetic StimulationWith the coil directed at the stellate ganglion, 60 minutes of 1Hz stimulation will be delivered targeting the stellate ganglion. |
| Theta Burst Stimulation TcMS | Active comparator | Device: Magnetic StimulationWith the coil directed at the stellate ganglion, 600 pulses of continuous theta burst stimulation will be delivered targeting the stellate ganglion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ≥3 episodes of sustained VT or appropriate ICD therapies within 24 hours despite the use of at least one antiarrhythmic drug
Key exclusion criteria (3 listed)
- Plan for catheter ablation of VT in the next 24 hours
- Pregnancy
- Contraindication to TcMS (i.e. implantable ventricular assist device, metal implanted in the head or neck [except the mouth], implanted medication pumps, cochlear implant, implanted brain stimulator, ocular implant, history of malignancy in the neck)
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 |
|---|---|---|
| Magnetic StimulationTranscutaneous Magnetic Stimulation | Device | Low Frequency TcMS, Sham Stimulation, Theta Burst Stimulation TcMS |
Primary outcome
VT Burden (24 hours)
Time frame: 24 hours after randomization
Number of episodes of sustained ventricular tachycardia
8 secondary outcomes
VT burden (72 hours)
Time frame: 72 hours after randomization
Freedom from VT
Time frame: 24 hours after randomization
Blood Pressure
Time frame: Immediately before and after stimulation
Heart Rate
Time frame: Immediately before and after stimulation
Pain
Time frame: Immediately after stimulation
Lead sensing
Time frame: Immediately before and after stimulation
Lead threshold
Time frame: Immediately before and after stimulation
Lead impedance
Time frame: Immediately before and after stimulation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: No
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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
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Stimulation 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 3 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: looking for participants now, as of the sponsor's last update on 21 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Timothy Markman (215-615-4332, timothy.markman@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VT Burden (24 hours) (time frame: 24 hours after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Apr 2026.