Randomized Assessment of TcMS for VT Storm

Not Applicable

Recruiting

• Conditions: Ventricular Tachycardia
• Interventions: Device: Magnetic Stimulation

• Registration Number: NCT05599022
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-24
• Study First Submitted QC: 2022-10-24
• Study First Posted: 2022-10-31
• Study Start: 2023-05-22
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-15
• Primary Completion: 2028-07
• Study Completion: 2028-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Stimulation	Magnetic Stimulation	With the coil directed away from the patient, 600 pulses of TcMS will be delivered at minimal energy output.
Low Frequency TcMS	Magnetic Stimulation	With the coil directed at the stellate ganglion, 60 minutes of 1Hz stimulation will be delivered targeting the stellate ganglion.
Theta Burst Stimulation TcMS	Magnetic Stimulation	With the coil directed at the stellate ganglion, 600 pulses of continuous theta burst stimulation will be delivered targeting the stellate ganglion.

Primary Outcome Measures

Name	Time	Method
VT Burden (24 hours)	24 hours after randomization	Number of episodes of sustained ventricular tachycardia

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States