Torque Device Evaluation

NCT ID: NCT07094256

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-25
• Study Completion Date: 2026-08-04

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Peritorq

Intervention Type: DEVICE

Novel torque device specifically designed for electrophysiology and ablation catheters

Interventions

Peritorq

Novel torque device specifically designed for electrophysiology and ablation catheters

Intervention Type: DEVICE

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)

• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Erick Jimenez

Role: CONTACT

jimen191@umn.edu

612-626-2830

Facility Contacts

Erick Jimenez

Role: primary

jimen191@umn.edu

612-626-2830

Other Identifiers

PEDS-2024-33423

Identifier Type: -

Identifier Source: org_study_id