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Recruiting NCT07094256

Torque Device Evaluation

No phase Interventional Electrophysiology Study Ablation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Peritorq.
Who it may be relevant to
Registry conditions: Electrophysiology Study, Ablation. Basic parameters: up to 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Evaluation of Novel Torque Device During Electrophysiology Study Procedure

Overview

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

  • Device Peritorq
    Novel torque device specifically designed for electrophysiology and ablation catheters

Primary outcome measures

  • Difference in Impedance [Time frame: 15 minutes]
  • Difference in Sensing of Chamber Amplitude (mV) [Time frame: 15 minutes]
  • Difference in Capture Threshold of Atrium and Ventricle (mA) [Time frame: 15 minutes]

Eligibility criteria

Inclusion criteria

  • Pediatric patient (≤21 years of age)
  • Undergoing clinically-indicated electrophysiology study and/or ablation procedure

Exclusion criteria

  • Adult patient (>21 years)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 2 centers
  • Children's National — Washington D.C.
  • University of Minnesota — Minneapolis

Identifiers

NCT: NCT07094256 · PEDS-2024-33423

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗