Torque Device Evaluation

Evaluation of Novel Torque Device During Electrophysiology Study Procedure

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.

Study Overview

• Status: Recruiting
• Conditions: Ablation; Electrophysiology Study
• Intervention / Treatment: Device: Peritorq

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bradley Clark; Phone Number: (612) 626-2755; Email: clarkb@umn.edu

Study Locations

• United States
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • Recruiting
      • Children's National
      • Contact: Charles Berul; Phone Number: 202-476-4132; Email: CBerul@childrensnational.org
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • University of Minnesota
      • Contact: Erick Jimenez; Phone Number: 612-626-2830; Email: jimen191@umn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Adult patient (>21 years)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Torque Device; 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; Novel torque device specifically designed for electrophysiology and ablation catheters

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Bradley Clark, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2025
• Primary Completion (Estimated): August 4, 2026
• Study Completion (Estimated): August 4, 2026

Study Registration Dates

• First Submitted: July 22, 2025
• First Submitted That Met QC Criteria: July 22, 2025
• First Posted (Actual): July 30, 2025

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: PEDS-2024-33423

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes