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Recruiting

NCT Number: NCT07094256

Torque Device Evaluation

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.

Recruiting

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Key information

Conditions

Electrophysiology Study Ablation

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's National, Washington D.C., District of Columbia, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Adult patient (>21 years)

Treatment and study plan

Peritorq

Device

Novel torque device specifically designed for electrophysiology and ablation catheters

Primary outcomes

  1. Difference in Impedance

    Time frame: 15 minutes

    Obtained from catheter at baseline and after Peritorq device placed

  2. Difference in Sensing of Chamber Amplitude (mV)

    Time frame: 15 minutes

    Obtained from catheter at baseline and after Peritorq device placed

  3. Difference in Capture Threshold of Atrium and Ventricle (mA)

    Time frame: 15 minutes

    Obtained from catheter at baseline and after Peritorq device placed

Study contacts

Contact information is provided by the study sponsor or research team.

Bradley Clark

CONTACT

[email protected]

(612) 626-2755

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

Evaluation of Novel Torque Device During Electrophysiology Study Procedure

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 30, 2025
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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