Harmony Transcatheter Pulmonary Valve (TPV) use in Europe
Harmony TPV EMEA Post-Market Study
Tests the Harmony transcatheter pulmonary valve in children and adults with severe pulmonary valve regurgitation who are candidates for valve replacement.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Sex | All |
| Sponsor | Medtronic Cardiovascular Industry-sponsored |
| Locations | 12 sites (Copenhagen and 11 other locations) |
| Trial ID | NCT06906926 on ClinicalTrials.gov |
What this trial studies
This is a prospective, non-randomized, multi-center post-market interventional study of the Harmony Transcatheter Pulmonary Valve for pediatric and adult congenital heart disease patients with severe pulmonary regurgitation. Eligible participants are those who meet the device Instructions for Use and local regulatory requirements and who are judged by their medical team to need pulmonary valve replacement. The protocol includes device implantation and scheduled follow-up visits with some imaging assessments that may be beyond standard care to document valve performance and clinical outcomes. Key exclusions include central vein obstruction, prior RV-PA conduit or prosthetic valves, intracardiac mass/infection, planned branch pulmonary artery stenting, pregnancy, or life expectancy under one year.
Who should consider this trial
Good fit: Children and adults with severe pulmonary regurgitation and a native or surgically repaired right ventricular outflow tract who meet the device IFU and are judged by their medical team to need pulmonary valve replacement are ideal candidates.
Not a fit: Patients with central vein obstruction, prior RV-PA conduit or existing prosthetic heart valves, active intracardiac mass/thrombus/infection, planned branch PA stenting, pregnancy, or a life expectancy under one year are excluded and unlikely to receive benefit from this device.
Why it matters
Potential benefit: If successful, the Harmony TPV could offer a less invasive option for pulmonary valve replacement that may reduce recovery time compared with open-heart surgery.
How similar studies have performed: Prior feasibility and post-market work with the Harmony TPV and other transcatheter pulmonary valves has reported favorable hemodynamic and clinical outcomes, so this study continues established post-market evaluation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Subject eligible to receive Harmony TPV System in conformity with Instructions for Use (IFU) and local regulations at time of study enrollment. 2. 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 Criteria: 1. Obstruction of the central veins. 2. Planned concomitant branch pulmonary artery stenting at time of implant. 3. Subjects previously treated with an RV-PA conduit or previously implanted bioprosthesis. 4. 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. 5. Planned implantation of the Harmony TPV in the left heart. 6. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation. 7. Pre-existing prosthetic heart valve or prosthetic ring in any position 8. Subject is pregnant as confirmed by a positive pregnancy test before implant procedure for female subjects of childbearing potential. 9. 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 this trial is running
Copenhagen and 11 other locations
- Rigshospitalet — Copenhagen, Denmark (Recruiting)
- CHU de Bordeaux - Hôpital Cardiologique du Haut-Leveque — Bordeaux, France (Recruiting)
- Herz - und Diabeteszentrum NRW — Bad Oeynhausen, Germany (Recruiting)
- Charité - Universitätsmedizin Berlin — Berlin, Germany (Recruiting)
- Helios Health Institute Standort Leipzig — Leipzig, Germany (Recruiting)
- TUM University Hospital — Munich, Germany (Recruiting)
- Mater Misericordiae University Hospital — Dublin, Ireland (Recruiting)
- Schneider Children's Medical Center Israel — Petah Tikva, Israel (Recruiting)
- Policlinico di Sant'Orsola — Bologna, Italy (Not_yet_recruiting)
- Azienda Ospedaliera di Padova — Padova, Italy (Not_yet_recruiting)
- Hospital General Universitario Gregorio Marañón — Madrid, Spain (Recruiting)
- Skånes Universitetssjukhus Lund — Lund, Sweden (Recruiting)
Study contacts
- Principal investigator: Peter Ewert, Prof. Dr. — TUM Klinikum Deutsches Herzzentrum
- Study coordinator: Petra Novakova
- Email: rs.harmonyemeapms@medtronic.com
- Phone: +31612591883
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.