Surgical Right Ventricular Outflow Tract Reconstruction for Truncus Arteriosus

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Truncus Arteriosus+7 More
Surgical Right Ventricular Outflow Tract Reconstruction - Device
Eligibility
< 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial is to test the safety and effectiveness of a new valve for people who need surgery to repair or replace their right ventricular outflow tract. The trial will help determine if the new valve is safe and effective enough to be used in future patients.

Eligible Conditions
  • Truncus Arteriosus
  • Pulmonary Stenosis
  • Transposition of Great Vessels
  • Pulmonary Atresia
  • Tetrology of Fallot
  • Ross Procedure

Treatment Effectiveness

Study Objectives

7 Primary · 3 Secondary · Reporting Duration: 1 year

1 year
Freedom from Device-Related Catheter Intervention
Freedom from Device-Related Reoperation
Freedom from Endocarditis
Freedom from Explant
Freedom from Major Hemorrhage
Freedom from Moderate or Greater Pulmonary Regurgitation
Freedom from Pulmonary Gradient ≥36mmHg
Freedom from Thrombus
Freedom from device related death
Freedom from device valve failure

Trial Safety

Trial Design

1 Treatment Group

Experimental Arm
1 of 1
Experimental Treatment

10 Total Participants · 1 Treatment Group

Primary Treatment: Surgical Right Ventricular Outflow Tract Reconstruction · No Placebo Group · N/A

Experimental Arm
Device
Experimental Group · 1 Intervention: Surgical Right Ventricular Outflow Tract Reconstruction · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year

Who is running the clinical trial?

PECA LabsLead Sponsor
David Morales, MDPrincipal InvestigatorCinncinnati Childrens Hospital
1 Previous Clinical Trials
16 Total Patients Enrolled

Eligibility Criteria

Age < 65 · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Patient's legal guardian should be willing to provide informed consent (IC) at the hospital location where they are being enrolled.
You are younger than 22 years.
You have a right ventricular to pulmonary artery mean gradient of 35mm Hg or greater, moderate or severe pulmonary regurgitation, or clinical indication for replacement of their native or prosthetic pulmonary valve with a prosthesis.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 15th, 2021

Last Reviewed: October 8th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.