Recruiting

Catheter Torque Device

Sponsor:

University of Minnesota

Code:

NCT07094256

Conditions

Electrophysiology Study

Ablation

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Interventions

Peritorq

Study Details

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 ID

NCT07094256

Start date

Aug 25, 2025

Status verified date

Aug, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • Adult patient (>21 years)

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

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

Interventions

Peritorq

Novel torque device specifically designed for electrophysiology and ablation catheters

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Bradley Clark

(612) 626-2755clarkb@umn.edu

Locations

Children's National

Recruiting

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

Contacts

Charles Berul

202-476-4132CBerul@childrensnational.org

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Erick Jimenez

612-626-2830jimen191@umn.edu

More Information

Sponsor

University of Minnesota

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-08-06.