New catheter torque device for pediatric electrophysiology and ablation procedures
Evaluation of Novel Torque Device During Electrophysiology Study Procedure
This will test a new catheter torque device to see if it's safe and works well in children and young adults having electrophysiology studies or ablations.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | N/A to 21 Years |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 2 sites (Washington D.C., District of Columbia and 1 other locations) |
| Trial ID | NCT07094256 on ClinicalTrials.gov |
What this trial studies
This interventional trial tests Peritorq, a novel catheter torque device, in pediatric patients (≤21 years) who have undergone a clinically indicated electrophysiology study and/or ablation. The device is applied only after the attending electrophysiologist has completed all necessary interventions and testing and does not change the clinical care plan. Safety and device performance data will be collected following completion of the clinically indicated procedure. Enrollment is limited to patients treated at participating sites.
Who should consider this trial
Good fit: Children and young adults aged 21 or younger who are already scheduled for a clinically indicated electrophysiology study and/or ablation at a participating center.
Not a fit: Adults over 21 and patients not undergoing an electrophysiology study or ablation are not eligible and would not be expected to benefit.
Why it matters
Potential benefit: If successful, the device could improve catheter control and procedural safety during pediatric electrophysiology and ablation procedures.
How similar studies have performed: While torque-control technologies for catheters exist, Peritorq is a novel device and pediatric-specific evidence is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pediatric patient (≤21 years of age) * Undergoing clinically-indicated electrophysiology study and/or ablation procedure Exclusion Criteria: * Adult patient (\>21 years)
Where this trial is running
Washington D.C., District of Columbia and 1 other locations
- Children's National — Washington D.C., District of Columbia, United States (Recruiting)
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Bradley Clark — University of Minnesota
- Study coordinator: Bradley Clark
- Email: clarkb@umn.edu
- Phone: (612) 626-2755
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.