Back to resultsRandomized Assessment of TcMS for VT Storm
Primary Purpose
Ventricular Tachycardia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Magnetic Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Ventricular Tachycardia
Eligibility 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)
Sites / Locations
- Hospital of the University of PennsylvaniaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Sham Stimulation
Low Frequency TcMS
Theta Burst Stimulation TcMS
Arm Description
With the coil directed away from the patient, 600 pulses of TcMS will be delivered at minimal energy output.
With the coil directed at the stellate ganglion, 60 minutes of 1Hz stimulation will be delivered targeting the stellate ganglion.
With the coil directed at the stellate ganglion, 600 pulses of continuous theta burst stimulation will be delivered targeting the stellate ganglion.
Outcomes
Primary Outcome Measures
VT Burden (24 hours)
Number of episodes of sustained ventricular tachycardia
Secondary Outcome Measures
VT burden (72 hours)
Number of episodes of sustained ventricular tachycardia
Freedom from VT
Freedom from sustained VT
Blood Pressure
Change in mean arterial blood pressure
Heart Rate
Change in heart rate
Pain
Pain at site of stimulation (0-10 scale)
Lead sensing
Change in implantable device lead sensing
Lead threshold
Change in implantable device lead pacing threshold
Lead impedance
Change in implantable device lead pacing impedance
Full Information
NCT ID
NCT05599022
First Posted
October 24, 2022
Last Updated
August 16, 2023
Sponsor
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT05599022
Brief Title
Randomized Assessment of TcMS for VT Storm
Official Title
Randomized Assessment of the Efficacy of Transcutaneous Magnetic Stimulation in Patients With Ventricular Tachycardia Storm
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2023 (Actual)
Primary Completion Date
June 2028 (Anticipated)
Study Completion Date
July 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Tachycardia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sham Stimulation
Arm Type
Placebo Comparator
Arm Description
With the coil directed away from the patient, 600 pulses of TcMS will be delivered at minimal energy output.
Arm Title
Low Frequency TcMS
Arm Type
Active Comparator
Arm Description
With the coil directed at the stellate ganglion, 60 minutes of 1Hz stimulation will be delivered targeting the stellate ganglion.
Arm Title
Theta Burst Stimulation TcMS
Arm Type
Active Comparator
Arm Description
With the coil directed at the stellate ganglion, 600 pulses of continuous theta burst stimulation will be delivered targeting the stellate ganglion.
Intervention Type
Device
Intervention Name(s)
Magnetic Stimulation
Intervention Description
Transcutaneous Magnetic Stimulation
Primary Outcome Measure Information:
Title
VT Burden (24 hours)
Description
Number of episodes of sustained ventricular tachycardia
Time Frame
24 hours after randomization
Secondary Outcome Measure Information:
Title
VT burden (72 hours)
Description
Number of episodes of sustained ventricular tachycardia
Time Frame
72 hours after randomization
Title
Freedom from VT
Description
Freedom from sustained VT
Time Frame
24 hours after randomization
Title
Blood Pressure
Description
Change in mean arterial blood pressure
Time Frame
Immediately before and after stimulation
Title
Heart Rate
Description
Change in heart rate
Time Frame
Immediately before and after stimulation
Title
Pain
Description
Pain at site of stimulation (0-10 scale)
Time Frame
Immediately after stimulation
Title
Lead sensing
Description
Change in implantable device lead sensing
Time Frame
Immediately before and after stimulation
Title
Lead threshold
Description
Change in implantable device lead pacing threshold
Time Frame
Immediately before and after stimulation
Title
Lead impedance
Description
Change in implantable device lead pacing impedance
Time Frame
Immediately before and after stimulation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Timothy Markman
Phone
215-615-4332
Email
timothy.markman@pennmedicine.upenn.edu
Facility Information:
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timothy Markman, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Randomized Assessment of TcMS for VT Storm
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