Torque Device Evaluation

NCT07094256 | Recruiting FDA Device

• 1 other identifier: PEDS-2024-33423
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

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.

Conditions

Electrophysiology Study; Ablation

Outcome Measures

Primary Outcomes (3)

• Difference in Impedance

  Obtained from catheter at baseline and after Peritorq device placed

  15 minutes

• Difference in Sensing of Chamber Amplitude (mV)

  Obtained from catheter at baseline and after Peritorq device placed

  15 minutes

• Difference in Capture Threshold of Atrium and Ventricle (mA)

  Obtained from catheter at baseline and after Peritorq device placed

  15 minutes

Study Arms (1)

Torque Device

EXPERIMENTAL

After the completion of the electrophysiology study and/or ablation procedure, the catheters remain in the intra-cardiac locations. While in place, measurements will be obtained from each catheter. Once the baseline measurements have been obtained, the Peritorq device will be placed onto each relevant catheter. Once secured, all measurements will be repeated with each catheter at the identical location. After measurements have been obtained, the operator will perform minor catheter movements to note subjective maneuverability and stability of the catheter with the torque device in place

Device: Peritorq

Interventions

Peritorq DEVICE

Novel torque device specifically designed for electrophysiology and ablation catheters

Torque Device

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Adult patient (\>21 years)

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (2)

Children's National

Washington D.C., District of Columbia, 20010, United States

RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

Study Officials

• Bradley Clark

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bradley Clark

CONTACT

(612) 626-2755; clarkb@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: July 30, 2025
• Study Start: August 25, 2025
• Primary Completion (Estimated): August 4, 2026
• Study Completion (Estimated): August 4, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)