Harmony TPV EMEA PMS
Recruiting now · Not applicable
Conditions studied: Severe Pulmonary Valve Regurgitation
In brief
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 pulmonary regurgitation as determined by echocardiography and/or pulmonary regurgitant fraction ≥ 30% as determined by cardiac magnetic resonance imaging) who have a native or surgically-repaired right ventricular outflow tract and are clinically indicated for pulmonary valve replacement as judged by the medical team.
Key facts
- Study ID
- NCT06906926
- Run by
- Medtronic Cardiovascular
- People needed
- 80
- Starts
- 2025-07-30
- Expected to finish
- 2032-12-31
- Last updated by the study team
- 2026-07-14
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Skånes Universitetssjukhus Lund — Lund, Sweden (enrolling)
- CHU de Bordeaux - Hôpital Cardiologique du Haut-Leveque — Bordeaux, France (enrolling)
- Herz - und Diabeteszentrum NRW — Bad Oeynhausen, Germany (enrolling)
- Charité - Universitätsmedizin Berlin — Berlin, Germany (enrolling)
- Helios Health Institute Standort Leipzig — Leipzig, Germany (enrolling)
- TUM University Hospital — Munich, Germany (enrolling)
- Mater Misericordiae University Hospital — Dublin, Ireland (enrolling)
- Schneider Children's Medical Center Israel — Petah Tikva, Israel (enrolling)
- Policlinico di Sant'Orsola — Bologna, Italy (enrolling)
- Rigshospitalet — Copenhagen, Denmark (enrolling)
- Hospital General Universitario Gregorio Marañón — Madrid, Spain (enrolling)
- Azienda Ospedaliera di Padova — Padova, Italy
Full record on ClinicalTrials.gov
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