Randomized Assessment of TcMS for VT Storm

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

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.

Study Overview

• Status: Recruiting
• Conditions: Ventricular Tachycardia
• Intervention / Treatment: Device: Magnetic Stimulation

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Timothy Markman; Phone Number: 215-615-4332; Email: timothy.markman@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Hospital of the University of Pennsylvania
      • Contact: Timothy Markman, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Sham Stimulation; With the coil directed away from the patient, 600 pulses of TcMS will be delivered at minimal energy output.	Device: Magnetic Stimulation; Transcutaneous Magnetic Stimulation
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.	Device: Magnetic Stimulation; Transcutaneous Magnetic Stimulation
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.	Device: Magnetic Stimulation; Transcutaneous Magnetic Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VT Burden (24 hours)	Number of episodes of sustained ventricular tachycardia	24 hours after randomization

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: October 24, 2022
• First Submitted That Met QC Criteria: October 24, 2022
• First Posted (Actual): October 31, 2022

Study Record Updates

• Last Update Posted (Actual): August 18, 2023
• Last Update Submitted That Met QC Criteria: August 16, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia; Tachycardia, Ventricular
• Other Study ID Numbers: 852176

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No