Ablation, Electrophysiology Study
Conditions
Brief summary
This study will evaluate the safety and efficacy of a novel catheter torque device after the completion of a clinically-indicated electrophysiology study and/or ablation procedure in a pediatric patient. All electrophysiology studies and/or ablation procedures will be performed at the discretion of their primary cardiologist and will not be affected by this study protocol. The study protocol will commence once the attending electrophysiologist has completed all necessary intervention and testing and no further evaluation is required.
Interventions
DEVICEPeritorq
Novel torque device specifically designed for electrophysiology and ablation catheters
Sponsors
University of Minnesota
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
No
Inclusion criteria
* Pediatric patient (≤21 years of age) * Undergoing clinically-indicated electrophysiology study and/or ablation procedure
Exclusion criteria
* Adult patient (\>21 years)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Impedance | 15 minutes | Obtained from catheter at baseline and after Peritorq device placed |
| Difference in Sensing of Chamber Amplitude (mV) | 15 minutes | Obtained from catheter at baseline and after Peritorq device placed |
| Difference in Capture Threshold of Atrium and Ventricle (mA) | 15 minutes | Obtained from catheter at baseline and after Peritorq device placed |
Countries
United States
Contacts
CONTACTBradley Clark
PRINCIPAL_INVESTIGATORBradley Clark
University of Minnesota
Outcome results
None listed