Torque Device Evaluation

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
University of Minnesota
Study ID
NCT07094256
Status
Recruiting

Conditions

  • Ablation
  • Electrophysiology Study

Eligibility Criteria

Sex
ALL
Age
N/A - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Peritorq — DEVICE
    Novel torque device specifically designed for electrophysiology and ablation catheters

Study Details

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.

Key Dates

Start date
Aug 25, 2025
Status verified
Feb 2026
Primary completion
Aug 4, 2026
Completion
Aug 4, 2026

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

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

Primary Outcome Measure

Difference in Impedance [ Time Frame: 15 minutes ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Children's NationalWashington D.C.District of Columbia20010
Charles Berul
202-476-4132
University of MinnesotaMinneapolisMinnesota55455
Erick Jimenez
612-626-2830

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