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NCT05599022 Clinical Trial

Randomized Assessment of TcMS for VT Storm

Ventricular Tachycardia Clinical Trial

Official title:
Randomized Assessment of the Efficacy of Transcutaneous Magnetic Stimulation in Patients With Ventricular Tachycardia Storm

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05599022
Other study ID # 852176
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 15, 2023
Est. completion date July 2028

Study information
Verified date August 2023
Source University of Pennsylvania
Contact Timothy Markman
Phone 215-615-4332
Email timothy.markman@pennmedicine.upenn.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date July 2028
Est. primary completion date June 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Magnetic Stimulation
Transcutaneous Magnetic Stimulation

Locations
Country Name City State
United States Hospital of the University of Pennsylvania Philadelphia Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary VT Burden (24 hours) Number of episodes of sustained ventricular tachycardia 24 hours after randomization
Secondary VT burden (72 hours) Number of episodes of sustained ventricular tachycardia 72 hours after randomization
Secondary Freedom from VT Freedom from sustained VT 24 hours after randomization
Secondary Blood Pressure Change in mean arterial blood pressure Immediately before and after stimulation
Secondary Heart Rate Change in heart rate Immediately before and after stimulation
Secondary Pain Pain at site of stimulation (0-10 scale) Immediately after stimulation
Secondary Lead sensing Change in implantable device lead sensing Immediately before and after stimulation
Secondary Lead threshold Change in implantable device lead pacing threshold Immediately before and after stimulation
Secondary Lead impedance Change in implantable device lead pacing impedance Immediately before and after stimulation
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