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Harmony TPV for Congenital Heart Disease

N/A
Recruiting
Led By David Balzer, MD
Research Sponsored by Medtronic Cardiovascular
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must not have
Positive pregnancy test at baseline (prior to CT angiography and again prior to implant procedure) in female subjects of childbearing potential
Obstruction of the central veins
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will test the Medtronic Harmony TPV in people to see if it works as intended.

Who is the study for?
This trial is for individuals with congenital heart defects who are eligible to receive the Harmony TPV as per current device labeling. Participants must consent to join the study. Exclusions include those with certain anatomical restrictions, central vein obstructions, infections, pregnancy, specific non-cardiac diseases reducing life expectancy under a year, known allergies to aspirin, heparin or nickel, and pre-existing prosthetic heart valves.
What is being tested?
The study aims to evaluate real-world outcomes of the Medtronic Harmony Transcatheter Pulmonary Valve (TPV) implantation in patients with right ventricular outflow tract anomalies due to congenital heart disease. It focuses on how well it works when implanted by various doctors in clinical practice.
What are the potential side effects?
While not explicitly listed for this trial summary provided, potential side effects may include complications related to catheter insertion such as bleeding or infection at the site of entry; allergic reactions; issues related to valve functionality like blockage or leakage; and general risks associated with heart procedures.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant, as confirmed by tests before certain procedures.
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My central veins are blocked.
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I have signs of an infection or active endocarditis.
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I had surgery to fix a heart valve issue with an RV-PA conduit.
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I do not have a serious illness besides my cancer that would limit my life to under a year.
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I am scheduled for a procedure to place stents in my lung arteries.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of subjects without valve reintervention and with acceptable hemodynamic function composite at 6 months as defined by
Secondary study objectives
Number and percentage of subjects with serious device-related adverse events at 6 months
Percentage of subjects free from TPV dysfunction at 6-months
Percentage of subjects free from all-cause mortality at 6-months
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Find a Location

Who is running the clinical trial?

Medtronic CardiovascularLead Sponsor
75 Previous Clinical Trials
36,017 Total Patients Enrolled
David Balzer, MDPrincipal InvestigatorSt. Louis Children's Hospital

Media Library

Harmony TPV System Clinical Trial Eligibility Overview. Trial Name: NCT05077774 — N/A
Congenital Heart Disease Research Study Groups: Harmony TPV System
Congenital Heart Disease Clinical Trial 2023: Harmony TPV System Highlights & Side Effects. Trial Name: NCT05077774 — N/A
Harmony TPV System 2023 Treatment Timeline for Medical Study. Trial Name: NCT05077774 — N/A
~26 spots leftby Oct 2025
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