Randomized Assessment of the Efficacy of Transcutaneous Magnetic Stimulation in Patients With Ventricular Tachycardia Storm
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• ≥3 episodes of sustained VT or appropriate ICD therapies within 24 hours despite the use of at least one antiarrhythmic drug
Locations
United States
Pennsylvania
Hospital of the University of Pennsylvania
RECRUITING
Philadelphia
Contact Information
Primary
Timothy Markman
timothy.markman@pennmedicine.upenn.edu
215-615-4332
Time Frame
Start Date: 2023-05-22
Estimated Completion Date: 2028-09
Participants
Target number of participants: 60
Treatments
Placebo_comparator: Sham Stimulation
With the coil directed away from the patient, 600 pulses of TcMS will be delivered at minimal energy output.
Active_comparator: Low Frequency TcMS
With the coil directed at the stellate ganglion, 60 minutes of 1Hz stimulation will be delivered targeting the stellate ganglion.
Active_comparator: Theta Burst Stimulation TcMS
With the coil directed at the stellate ganglion, 600 pulses of continuous theta burst stimulation will be delivered targeting the stellate ganglion.
Related Therapeutic Areas
Sponsors
Leads: University of Pennsylvania