Torque Device Evaluation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 21
SponsorUniversity of Minnesota
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pediatric patient (≤21 years of age)
Undergoing clinically-indicated electrophysiology study and/or ablation procedure
Disqualifiers
Adult patient (>21 years)
Trial design
Design model
Single group
Treatments tested in this trial
Peritorq
DeviceNovel torque device specifically designed for electrophysiology and ablation catheters
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Torque DeviceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Difference in Impedance
Obtained from catheter at baseline and after Peritorq device placed
Time frame
15 minutes2
Difference in Sensing of Chamber Amplitude (mV)
Obtained from catheter at baseline and after Peritorq device placed
Time frame
15 minutes3
Difference in Capture Threshold of Atrium and Ventricle (mA)
Obtained from catheter at baseline and after Peritorq device placed
Time frame
15 minutesSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov