Ventricular TachycardiaNCT05016921
TcMS to Treat Ventricular Tachycardia
A study testing TcMS in people with Ventricular Tachycardia, run by University of Pennsylvania at 1 site in United States.
Trial summary
Open label study of transcutaneous magnetic stimulation targeting the stellate ganglion in patients with ventricular tachycardia 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?
- TcMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2024to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age >18years
- Documented ventricular tachycardia within the preceding 72 hours
Who cannot join
- Pregnancy
- Implanted ventricular assist device
- Metal implanted in heard or neck (except the mouth)
- Implanted medication pumps
- Cochlear implant
- Implanted brain stimulator
- Ocular implant
- History of malignancy in the 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: Transcutaneous Magnetic Stimulation of the Stellate Ganglion to Treat Ventricular Tachycardia
Open label study of transcutaneous magnetic stimulation targeting the stellate ganglion in patients with ventricular tachycardia
- Conditions
- Ventricular Tachycardia
- Being tested
- TcMS
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TcMSDevice
Transcutaneous magnetic stimulation targeting the stellate ganglion
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous magnetic stimulation | Experimental | Transcutaneous magnetic stimulation targeting the stellate ganglion Receives: Device: TcMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventricular Tachycardia
Burden (number of episodes) of ventricular tachycardia
Measured: 0-72 hours after enrollment
Secondary outcomes (2)
Non sustained ventricular tachycardia
Burden (number of episodes) of ventricular tachycardia
Measured: 0-72 hours after enrollment
Discomfort
Discomfort experienced during stimulation (on scale of 0-10) reported by patient
Measured: Assessed immediately following stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start1 Jan 2024
- Primary completion1 Jan 2024
- Study completion1 Jan 2024 (estimated)
Why it stopped: Alternate study pursued
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT05016921
- Sponsor's protocol ID
- 849193
- Status last verified
- Apr 2024
- First submitted
- 16 Aug 2021
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Magnetic Stimulation of the Stellate Ganglion to Treat Ventricular Tachycardia
- ClinicalTrials.gov ID
- NCT05016921
- Acronym / sponsor ID
- 849193
- Conditions
- Ventricular Tachycardia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Alternate study pursued
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 23 Aug 2021 (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.
Open label study of transcutaneous magnetic stimulation targeting the stellate ganglion in patients with ventricular tachycardia
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous magnetic stimulation | Experimental | Device: TcMSTranscutaneous magnetic stimulation 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 (2 listed)
- Age >18years
- Documented ventricular tachycardia within the preceding 72 hours
Key exclusion criteria (8 listed)
- Pregnancy
- Implanted ventricular assist device
- Metal implanted in heard 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 |
|---|---|---|
| TcMSTranscutaneous magnetic stimulation targeting the stellate ganglion | Device | Transcutaneous magnetic stimulation |
Primary outcome
Ventricular Tachycardia
Time frame: 0-72 hours after enrollment
Burden (number of episodes) of ventricular tachycardia
2 secondary outcomes
Non sustained ventricular tachycardia
Time frame: 0-72 hours after enrollment
Discomfort
Time frame: Assessed immediately following stimulation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- 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
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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)
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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 TcMS 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 2 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: withdrawn, as of the sponsor's last update on 4 Apr 2024. 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 (time frame: 0-72 hours after enrollment). 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 4 Apr 2024.