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Transcatheter Pulmonary Valve

Transcatheter Pulmonary Valve Therapy for Pulmonary Regurgitation

N/A
Waitlist Available
Led By John P Cheatham, MD
Research Sponsored by Medtronic Heart Valves
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject has clinical indication for surgical placement of an RV-PA conduit or bioprosthetic pulmonary valve
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 year, 5 year (4 & 5 year data has an anticipated reporting date of april 2025)
Awards & highlights

Study Summary

This trial is testing a new system to see if it is safe and effective.

Who is the study for?
This trial is for individuals with severe pulmonary regurgitation, often due to congenital heart defects like Tetralogy of Fallot. Participants need a clinical indication for an RV-PA conduit or bioprosthetic pulmonary valve and must consent to join. It's not suitable for those previously treated with an RV-to-PA conduit implant, have unfavorable RVOT anatomy, are pregnant, or have a life expectancy under one year.Check my eligibility
What is being tested?
The study is evaluating the Harmony TPV System's safety and effectiveness in treating conditions that affect the flow of blood from the right ventricle to the lungs caused by congenital heart issues.See study design
What are the potential side effects?
While specific side effects aren't listed here, similar procedures may include risks such as bleeding, infection at the catheter insertion site, arrhythmias (irregular heartbeats), or damage to blood vessels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I need surgery to replace or repair my pulmonary valve.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 year, 5 year (2 & 5 year data has an anticipated reporting date of april 2025)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 year, 5 year (2 & 5 year data has an anticipated reporting date of april 2025) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Freedom From Procedure- or Device-related Mortality at 30 Days.
Number of Participants With Acceptable Hemodynamic Function Composite at 6 Months
Secondary outcome measures
Assessment of Safety
Characterization of Quality of Life Scores Out to 5 Years
Characterization of Right Ventricle Remodeling Following TPV Implant
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Harmony TPV SystemExperimental Treatment1 Intervention
Intervention Device: Harmony Transcatheter Pulmonary Valves and Delivery Systems

Find a Location

Who is running the clinical trial?

Medtronic Heart ValvesLead Sponsor
2 Previous Clinical Trials
59 Total Patients Enrolled
John P Cheatham, MDPrincipal InvestigatorNationwide Children's Hospital

Media Library

Harmony TPV System (Transcatheter Pulmonary Valve) Clinical Trial Eligibility Overview. Trial Name: NCT02979587 — N/A
Pulmonary Regurgitation Research Study Groups: Harmony TPV System
Pulmonary Regurgitation Clinical Trial 2023: Harmony TPV System Highlights & Side Effects. Trial Name: NCT02979587 — N/A
Harmony TPV System (Transcatheter Pulmonary Valve) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02979587 — N/A
~10 spots leftby Jun 2025
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