Transcatheter Pulmonary Valve Therapy for Pulmonary Regurgitation
Recruiting in Palo Alto (17 mi)
+11 other locations
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Medtronic Heart Valves
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?The purpose of this study is to further evaluate the safety and effectiveness of the Harmony™ TPV system. The Pivotal/CAS phases of the study have transitioned into a post-approval study to confirm the long-term functionality of transcatheter implantation of the Medtronic Harmony TPV.
Eligibility Criteria
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.Inclusion Criteria
You have a serious heart valve problem called pulmonary regurgitation, as shown by certain heart tests.
I need surgery to replace or repair my pulmonary valve.
Subject is willing to consent to participate
Exclusion Criteria
The anatomy or shape of the right ventricular outflow tract (RVOT) is not suitable for anchoring the device.
I had surgery to fix a heart valve issue with an implant.
You are pregnant.
+1 more
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Harmony TPV SystemExperimental Treatment1 Intervention
Intervention Device: Harmony Transcatheter Pulmonary Valves and Delivery Systems
Harmony TPV System is already approved in United States, Japan for the following indications:
🇺🇸 Approved in United States as Harmony TPV System for:
- Severe pulmonary valve regurgitation associated with native or surgically repaired right ventricular outflow tract (RVOT)
🇯🇵 Approved in Japan as Harmony TPV System for:
- Severe pulmonary valve regurgitation associated with native or surgically repaired right ventricular outflow tract (RVOT)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Toronto General HospitalToronto, Canada
Ronald Regan UCLA Medical CenterLos Angeles, CA
Stanford University Medical CenterPalo Alto, CA
Yale UniversityNew Haven, CT
More Trial Locations
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Who Is Running the Clinical Trial?
Medtronic Heart ValvesLead Sponsor