Torque Device Evaluation

University of Minnesota (UMN)

Status: Enrolling

Conditions: Ablation; Electrophysiology Study

Treatments: Device: Peritorq

Study type: Interventional

Funder types: Other

Identifiers

NCT07094256

PEDS-2024-33423

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: All

Ages: Under 21 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Adult patient (>21 years)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Torque Device

Experimental group

Description:

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

Treatment:

Device: Peritorq