Children's National

Torque Device Evaluation

Purpose

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

Eligibility

Eligible Ages: Under 21 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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

Phase: N/A
Study Type: Interventional
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Other
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
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

Recruiting Locations

Children's National and nearby locations

Children's National
Washington D.C. 4140963, District of Columbia 4138106 20010

Contact:
Charles Berul
202-476-4132
CBerul@childrensnational.org

More Details

NCT ID: NCT07094256
Status: Recruiting
Sponsor: University of Minnesota

Study Contact

Bradley Clark
(612) 626-2755
clarkb@umn.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.