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NCT Number: NCT05599022

Randomized Assessment of TcMS for VT 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.

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Key information

Conditions

Ventricular Tachycardia Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Ventricular

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Location contact

Timothy Markman, MD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

magnetic stimulation

Device

Transcutaneous Magnetic Stimulation

Primary outcomes

  1. VT Burden (24 hours)

    Time frame: 24 hours after randomization

    Number of episodes of sustained ventricular tachycardia

Secondary outcomes

  1. VT burden (72 hours)

    Time frame: 72 hours after randomization

    Number of episodes of sustained ventricular tachycardia

  2. Freedom from VT

    Time frame: 24 hours after randomization

    Freedom from sustained VT

  3. Blood Pressure

    Time frame: Immediately before and after stimulation

    Change in mean arterial blood pressure

  4. Heart Rate

    Time frame: Immediately before and after stimulation

    Change in heart rate

  5. Pain

    Time frame: Immediately after stimulation

    Pain at site of stimulation (0-10 scale)

  6. Lead sensing

    Time frame: Immediately before and after stimulation

    Change in implantable device lead sensing

  7. Lead threshold

    Time frame: Immediately before and after stimulation

    Change in implantable device lead pacing threshold

  8. Lead impedance

    Time frame: Immediately before and after stimulation

    Change in implantable device lead pacing impedance

Study contacts

Contact information is provided by the study sponsor or research team.

Timothy Markman

CONTACT

[email protected]

215-615-4332

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Oct 31, 2022
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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