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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
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.Check my eligibility
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.See study design
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:Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of subjects without valve reintervention and with acceptable hemodynamic function composite at 6 months as defined by
Secondary outcome measures
Number and percentage of subjects with procedure success at 30-days
Number and percentage of subjects with serious device-related adverse events at 6 months
Percentage of subjects free from TPV dysfunction at 6-months
+3 moreTrial 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
36,221 Total Patients Enrolled
David Balzer, MDPrincipal InvestigatorSt. Louis Children's Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant, as confirmed by tests before certain procedures.My central veins are blocked.I have signs of an infection or active endocarditis.I had surgery to fix a heart valve issue with an RV-PA conduit.Your body cannot fit a specific size of medical tubing.You have an artificial heart valve or ring.You are able to use the Harmony TPV device according to the instructions in your area.I do not have a serious illness besides my cancer that would limit my life to under a year.I am scheduled for a procedure to place stents in my lung arteries.An ultrasound of your heart shows a mass, blood clot, or infection.You are planning to have the Harmony TPV implanted in your left heart.You are allergic to aspirin, heparin, or nickel.
Research Study Groups:
This trial has the following groups:- Group 1: Harmony TPV System
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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