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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
Must not have
Patients with right ventricular outflow tract obstruction (RVOTO) lesions surgically treated with an RV-to-PA conduit implant
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
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.
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.
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 belowSelect...
I need surgery to replace or repair my pulmonary valve.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I had surgery to fix a heart valve issue with an implant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 year, 5 year (2 & 5 year data has an anticipated reporting date of april 2025)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 year, 5 year (2 & 5 year data has an anticipated reporting date of april 2025)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Freedom From Procedure- or Device-related Mortality at 30 Days.
Number of Participants With Acceptable Hemodynamic Function Composite at 6 Months
Secondary study objectives
Assessment of Safety
Characterization of Quality of Life Scores Out to 5 Years
Characterization of Right Ventricle Remodeling Following TPV Implant
+4 moreTrial 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a serious heart valve problem called pulmonary regurgitation, as shown by certain heart tests.The anatomy or shape of the right ventricular outflow tract (RVOT) is not suitable for anchoring the device.I need surgery to replace or repair my pulmonary valve.I had surgery to fix a heart valve issue with an implant.You are pregnant.You are expected to live for less than a year.
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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