Randomized Assessment of TcMS for VT Storm
Randomized Assessment of the Efficacy of Transcutaneous Magnetic Stimulation in Patients With Ventricular Tachycardia Storm
1 other identifier
interventional
60
1 country
1
Brief 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 effective at reducing VT burden than low frequency TcMS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2022
CompletedFirst Posted
Study publicly available on registry
October 31, 2022
CompletedStudy Start
First participant enrolled
May 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2028
April 21, 2026
April 1, 2026
5.1 years
October 24, 2022
April 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
VT Burden (24 hours)
Number of episodes of sustained ventricular tachycardia
24 hours after randomization
Secondary Outcomes (8)
VT burden (72 hours)
72 hours after randomization
Freedom from VT
24 hours after randomization
Blood Pressure
Immediately before and after stimulation
Heart Rate
Immediately before and after stimulation
Pain
Immediately after stimulation
- +3 more secondary outcomes
Study Arms (3)
Sham Stimulation
PLACEBO COMPARATORWith the coil directed away from the patient, 600 pulses of TcMS will be delivered at minimal energy output.
Low Frequency TcMS
ACTIVE COMPARATORWith the coil directed at the stellate ganglion, 60 minutes of 1Hz stimulation will be delivered targeting the stellate ganglion.
Theta Burst Stimulation TcMS
ACTIVE COMPARATORWith the coil directed at the stellate ganglion, 600 pulses of continuous theta burst stimulation will be delivered targeting the stellate ganglion.
Interventions
Transcutaneous Magnetic Stimulation
Eligibility Criteria
You may qualify if:
- ≥3 episodes of sustained VT or appropriate ICD therapies within 24 hours despite the use of at least one antiarrhythmic drug
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 24, 2022
First Posted
October 31, 2022
Study Start
May 22, 2023
Primary Completion (Estimated)
July 1, 2028
Study Completion (Estimated)
October 1, 2028
Last Updated
April 21, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share