Comparing magnetic stimulation methods for treating ventricular tachycardia storms
Randomized Assessment of the Efficacy of Transcutaneous Magnetic Stimulation in Patients With Ventricular Tachycardia Storm
This study is testing two different types of magnetic stimulation treatments to see which one helps people with ventricular tachycardia storms feel better compared to a fake treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT05599022 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of two different strategies of transcranial magnetic stimulation (TcMS) in patients experiencing ventricular tachycardia (VT) storms. It is a three-arm randomized trial that compares TcMS with theta burst stimulation (TBS) and low-frequency TcMS against a sham stimulation group. The primary hypothesis is that TcMS will significantly reduce the burden of VT within 24 hours post-randomization compared to sham stimulation. The study aims to determine which TcMS approach is more effective in managing this critical condition.
Who should consider this trial
Good fit: Ideal candidates include individuals who have experienced three or more episodes of sustained ventricular tachycardia or appropriate ICD therapies within 24 hours despite antiarrhythmic drug treatment.
Not a fit: Patients who are scheduled for catheter ablation of VT within the next 24 hours or have contraindications to TcMS will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel non-invasive treatment option for patients suffering from recurrent ventricular tachycardia.
How similar studies have performed: While the approach of using TcMS for VT storms is innovative, similar studies have shown promise in using magnetic stimulation for other neurological and cardiac conditions, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Philadelphia, Pennsylvania
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Timothy Markman
- Email: timothy.markman@pennmedicine.upenn.edu
- Phone: 215-615-4332
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.