Randomized Assessment of TcMS for VT Storm
ConditionVentricular Tachycardia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pennsylvania
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
≥3 episodes of sustained VT or appropriate ICD therapies within 24 hours despite the use of at least one antiarrhythmic drug
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Magnetic Stimulation
DeviceTranscutaneous Magnetic Stimulation
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Sham StimulationPlacebo comparator 1 intervention
Group B: Low Frequency TcMSActive comparator 1 intervention
Group C: Theta Burst Stimulation TcMSActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
VT Burden (24 hours)
Number of episodes of sustained ventricular tachycardia
Time frame
24 hours after randomizationSecondary outcomes
1
VT burden (72 hours)
Number of episodes of sustained ventricular tachycardia
Time frame
72 hours after randomization2
Freedom from VT
Freedom from sustained VT
Time frame
24 hours after randomization3
Blood Pressure
Change in mean arterial blood pressure
Time frame
Immediately before and after stimulation4
Heart Rate
Change in heart rate
Time frame
Immediately before and after stimulationSponsors and contacts
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Source ClinicalTrials.gov