Randomized Assessment of TcMS for VT Storm
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Magnetic Stimulation.
- Who it may be relevant to
- Registry conditions: Ventricular Tachycardia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Randomized Assessment of the Efficacy of Transcutaneous Magnetic Stimulation in Patients With Ventricular Tachycardia Storm
Overview
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.
Interventions
- Device Magnetic Stimulation
Transcutaneous Magnetic Stimulation
Primary outcome measures
- VT Burden (24 hours) [Time frame: 24 hours after randomization]
Secondary outcome measures (8)
- 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]
Eligibility criteria
Inclusion criteria
- ≥3 episodes of sustained VT or appropriate ICD therapies within 24 hours despite the use of at least one antiarrhythmic drug
Exclusion criteria
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Hospital of the University of Pennsylvania — Philadelphia
Identifiers
NCT: NCT05599022 · 852176