- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07094256
Testing a New Torque Device for Heart Ablation Procedures in Children and Young Adults
This clinical trial is studying a new medical device called Peritorq, which is designed to help doctors perform heart mapping procedures (electrophysiology studies) and ablation treatments more effectively in pediatric patients and young adults up to age 21. The study will measure how this torque device affects important heart signals during these procedures.
The research team will compare measurements taken from heart catheters before and after using the Peritorq device. They'll look at three key factors: (1) electrical resistance (impedance), (2) heart signal strength (chamber amplitude), and (3) the minimum energy needed to make the heart respond (capture threshold). Doctors will also evaluate how easy the catheters are to move when using this new device.
This study is important because children's hearts are smaller and more delicate than adult hearts, requiring special tools and techniques. Current torque devices weren't specifically designed for pediatric electrophysiology procedures. The Peritorq device could potentially help doctors:
- Get more accurate measurements during heart mapping
- Position catheters more precisely during ablation
- Reduce procedure time
- Improve overall safety for young patients
Only 25 participants will be enrolled at the University of Minnesota, with the study running from August 2025 to August 2026. All participants must be undergoing heart procedures that are medically necessary - healthy volunteers cannot participate.
For families considering this trial, it's important to understand that this is an early evaluation of a new device. While there may be no direct benefit to participants, the knowledge gained could help improve care for future pediatric heart patients. The procedure follows standard clinical practice with the addition of some extra measurements using the investigational device.
Research in pediatric cardiology devices is crucial because children aren't just small adults - their growing bodies have unique needs. Many cardiac devices are initially designed for adults and later adapted for children, which isn't always ideal. Studies like this that focus specifically on pediatric tools help ensure our youngest heart patients receive care tailored to their specific anatomy and physiology.
The field of pediatric electrophysiology has made tremendous advances in recent decades, allowing doctors to treat heart rhythm problems in children with minimally invasive techniques rather than open-heart surgery. However, there's always room for improvement in catheter technology, especially for delicate procedures in small hearts. This research represents an important step toward developing specialized tools for our most vulnerable cardiac patients.
Families interested in learning more about this study should discuss it with their child's cardiologist, who can help determine if participation might be appropriate. As with any clinical trial, it's important to weigh potential risks and benefits while considering your child's specific medical needs and overall health status.
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