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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham Stimulation | Placebo Comparator | With the coil directed away from the patient, 600 pulses of TcMS will be delivered at minimal energy output. |
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| Low Frequency TcMS | Active Comparator | With the coil directed at the stellate ganglion, 60 minutes of 1Hz stimulation will be delivered targeting the stellate ganglion. |
|
| Theta Burst Stimulation TcMS | Active Comparator | With the coil directed at the stellate ganglion, 600 pulses of continuous theta burst stimulation will be delivered targeting the stellate ganglion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Stimulation | Device | Transcutaneous Magnetic Stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| VT Burden (24 hours) | Number of episodes of sustained ventricular tachycardia | 24 hours after randomization |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Timothy Markman | Contact | 215-615-4332 | timothy.markman@pennmedicine.upenn.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 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 |
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |