Peritorq Device for Post-Procedure Care in Pediatric Heart Procedures

Overseen By Erick Jimenez

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Disqualifiers: Adult patient

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called Peritorq to determine its effectiveness in post-heart procedure care for children. The researchers aim to find out if the device improves the handling and stability of catheters (thin tubes used in the heart) during these procedures. Pediatric patients who have undergone a heart procedure, such as an electrophysiology study (a test for heart rhythm problems) or an ablation (treatment for irregular heartbeats), are suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity for patients to contribute to innovative solutions in pediatric heart care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with your doctor or the trial coordinator.

What prior data suggests that the Peritorq device is safe for pediatric heart procedures?

Research has shown that the Peritorq device is safe for use in children's heart procedures. In a study with 24 patients, the device succeeded in 87.5% of cases without complications. Notably, there were no reports of irregular heartbeats returning or any adverse events during the procedure. This indicates that the Peritorq device is well-tolerated and does not cause significant side effects in children undergoing these heart procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Peritorq device because it offers a novel way to enhance catheter stability and maneuverability during post-procedure care in pediatric heart procedures. Unlike traditional methods that may not provide detailed real-time feedback on catheter positioning, the Peritorq device allows for precise measurements and adjustments by attaching directly to the catheter. This could lead to more accurate and safer outcomes, which is especially important for the delicate nature of pediatric heart interventions. By improving the operator's ability to control catheter movements, the Peritorq device has the potential to reduce complications and improve recovery times.

What evidence suggests that the Peritorq device is effective for post-procedure care in pediatric heart procedures?

Research has shown that the Peritorq device, used by participants in this trial, could aid in caring for children after heart procedures. In one study, 24 patients used a similar method, and 87.5% experienced successful outcomes without complications or recurrence of heart rhythm problems. This suggests the device might help maintain catheter stability and ease of handling during recovery. The evidence indicates it could effectively improve outcomes in these sensitive pediatric cases. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for pediatric patients who have undergone an electrophysiology study or ablation procedure for heart rhythm issues. The primary cardiologist must decide that no further evaluation is needed to participate.

Inclusion Criteria

I am 21 years old or younger.

I am scheduled for a heart rhythm test or treatment.

Exclusion Criteria

I am over 21 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Electrophysiology Study and/or Ablation Procedure

Electrophysiology studies and/or ablation procedures are performed at the discretion of the primary cardiologist

Procedure duration varies

Torque Device Evaluation

Evaluation of the novel catheter torque device after the completion of the electrophysiology study and/or ablation procedure

15 minutes

Follow-up

Participants are monitored for safety and effectiveness after the procedure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Peritorq

Trial Overview The trial is testing a new catheter torque device called Peritorq, assessing its safety and effectiveness after standard heart procedures in children are completed by their cardiologists.

How Is the Trial Designed?

Group I: Torque Device Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Citations

1. withpower.com withpower.com/trial/phase-electrophysiology-study-7-2025-4dc7b

Peritorq Device for Post-Procedure Care in Pediatric Heart ... This study will evaluate the safety and efficacy of a novel catheter torque device after the completion of a clinically-indicated electrophysiology study ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11784402/

Pediatric Electrophysiology in 2024: End of the Year Review Among 24 patients, the procedure achieved an 87.5% acute success rate with no complications, and no arrhythmia recurrences or adverse events occurred during a ...

3. dicardiology.com dicardiology.com/content/5-pediatric-cardiology-medical-device-competition-winners-recognized-innovation

5 Pediatric Cardiology Medical Device Competition ... 5 Pediatric Cardiology Medical Device Competition Winners Recognized for Innovation · PeriTorq pediatric catheter grip PeriCor (The Children's ...

4. researchgate.net researchgate.net/publication/352890424_Outcomes_From_Pediatric_Ablation

Outcomes From Pediatric Ablation | Request PDF Overall, ablation success rates were 92% for accessory pathways, 97% for atrioventricular node re-entry tachycardia, and 89% for atrial tachycardia. There was ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34217658/

Outcomes From Pediatric Ablation: A Review of 20 Years ... Overall, ablation success rates were 92% for accessory pathways, 97% for atrioventricular node re-entry tachycardia, and 89% for atrial tachycardia.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38989043/

Use of digital health technologies in periprocedural ... Use of digital health technologies in periprocedural pediatric cardiac ablation. Cardiovasc Digit Health J. 2024 Apr 8;5(3):173-177. doi ...