Status:
RECRUITING
Harmony TPV EMEA PMS
Lead Sponsor:
Medtronic Cardiovascular
Conditions:
Severe Pulmonary Valve Regurgitation
Eligibility:
All Genders
Phase:
NA
Brief Summary
The Harmony Transcatheter Pulmonary Valve (TPV) System is indicated for use in the management of pediatric and adult congenital heart disease patients with severe pulmonary regurgitation (i.e., severe...
Detailed Description
Prospective, non-randomized, multi-center, post-market interventional clinical study
Eligibility Criteria
Inclusion
- Subject eligible to receive Harmony TPV System in conformity with Instructions for Use (IFU) and local regulations at time of study enrollment.
- Subject or subject's parent(s)/legal guardian(s) must be willing and able to consent to participate in the study and will commit to completion of all follow-up requirements
Exclusion
- Obstruction of the central veins.
- Planned concomitant branch pulmonary artery stenting at time of implant.
- Subjects previously treated with an RV-PA conduit or previously implanted bioprosthesis.
- A major or progressive non-cardiac disease (e.g. liver failure, renal failure, cancer) that results in a life expectancy of less than one year.
- Planned implantation of the Harmony TPV in the left heart.
- Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
- Pre-existing prosthetic heart valve or prosthetic ring in any position
- Subject is pregnant as confirmed by a positive pregnancy test before implant procedure for female subjects of childbearing potential.
- Subjects that are vulnerable as defined in the Section 10.5 Subject Consent
- Subject Consent Section excerpt:
- Vulnerable adults, defined as subjects incapable of giving consent, as assessed per Investigator's opinion and in consideration of vulnerable adult definition per ISO 14155, will not be included in this study.
- Any subject with mental incompetence (e.g. Alzheimer's, dementia, psychiatric disorders, developmental disorders, chromosomal abnormalities with associated cognitive impairment) should be assessed by the Investigator for vulnerable status. If pediatric or adult subject is deemed by the Investigator mentally incompetent as described above, the subject will not be included in this study.
Key Trial Info
Start Date :
July 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2032
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06906926
Start Date
July 30 2025
End Date
December 31 2032
Last Update
December 22 2025
Active Locations (12)
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1
Rigshospitalet
Copenhagen, Denmark
2
CHU de Bordeaux - Hôpital Cardiologique du Haut-Leveque
Bordeaux, France, 33600
3
Herz - und Diabeteszentrum NRW
Bad Oeynhausen, Germany
4
Charité - Universitätsmedizin Berlin
Berlin, Germany, 12203