Clinical Trials Logo
  1. Home
  2. Ventricular Tachycardia
  3. NCT05599022
  4. Details
NCT05599022 Clinical Trial

Randomized Assessment of TcMS for VT Storm

Ventricular Tachycardia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05599022
Other study ID # 852176
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 15, 2023
Est. completion date July 2028

Study information
Verified date August 2023
Source University of Pennsylvania
Contact Timothy Markman
Phone 215-615-4332
Email timothy.markman@pennmedicine.upenn.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date July 2028
Est. primary completion date June 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Magnetic Stimulation
Transcutaneous Magnetic Stimulation

Locations
Country Name City State
United States Hospital of the University of Pennsylvania Philadelphia Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary VT Burden (24 hours) Number of episodes of sustained ventricular tachycardia 24 hours after randomization
Secondary VT burden (72 hours) Number of episodes of sustained ventricular tachycardia 72 hours after randomization
Secondary Freedom from VT Freedom from sustained VT 24 hours after randomization
Secondary Blood Pressure Change in mean arterial blood pressure Immediately before and after stimulation
Secondary Heart Rate Change in heart rate Immediately before and after stimulation
Secondary Pain Pain at site of stimulation (0-10 scale) Immediately after stimulation
Secondary Lead sensing Change in implantable device lead sensing Immediately before and after stimulation
Secondary Lead threshold Change in implantable device lead pacing threshold Immediately before and after stimulation
Secondary Lead impedance Change in implantable device lead pacing impedance Immediately before and after stimulation
See also
  Status Clinical Trial Phase
Recruiting NCT03453645 - Modification of Rhythmic Risk Assessment by Ventricular Tachycardia Ablation
Completed NCT05791032 - Sub Chronic Evaluation for ATP With an Extravascular Placed ICD Lead (STEP ICD) Study N/A
Completed NCT05970120 - A Study of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter N/A
Completed NCT04011631 - Evaluation of the iD-SystemTM, One-Handed Disposable Internal Defibrillation System. N/A
Recruiting NCT03536052 - Ablation at Virtual-hEart pRedicted Targets for VT N/A
Not yet recruiting NCT06063811 - Ventricular Tachycardia Ablation in LVAD Patients
Enrolling by invitation NCT02962076 - Study of Cardiac PET/CT Imaging to Guide Ablation Treatment of Ventricular Tachycardia Early Phase 1
Not yet recruiting NCT02784912 - Biomarkers in Risk Stratification of Sustainted Ventricular Tachycardia or Electrical Storm After Ablation N/A
Completed NCT01791543 - Intramural Needle Ablation for Ablation of Recurrent Ventricular Tachycardia N/A
Terminated NCT02891863 - Low Energy Therapy to Convert Ventricular Tachycardias Phase 0
Terminated NCT01546207 - Stepwise Approach To sUbstrate Modification for Ventricular Tachycardia N/A
Completed NCT01294267 - Percutaneous Hemodynamic Support With Impella 2.5 During Scar-related Ventricular Tachycardia Ablation N/A
Terminated NCT00383799 - Iv Amiodarone Versus Iv Procainamide to Treat Haemodynamically Well Tolerated Ventricular Tachycardia Phase 4
Completed NCT04884100 - enHEART - Exploring Full Content of Optical Signals to Enhance Cardiac Arrhythmia Screening N/A
Completed NCT04642963 - Stereotactic Management of Arrhythmia - Radiosurgery in Treatment of Ventricular Tachycardia N/A
Recruiting NCT05377216 - Characterization of Cardiac Electrophysiological Effects of Autonomic Neuromodulation Early Phase 1
Not yet recruiting NCT04990089 - VIVO European Observational Registry
Completed NCT04065893 - Impact of Catheter Ablation of Ventricular Arrhythmias on Suboptimal Biventricular Pacing in Cardiac Resynchronization Therapy
Recruiting NCT03631303 - Post-Extrasystolic Potentiation as a Predictor of Ventricular Arrhythmias
Recruiting NCT03611465 - Creation of a Pace-mapping Atlas on Healthy and Pathological Hearts N/A