Harmony Transcatheter Pulmonary Valve (TPV) use in Europe

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: Peter Ewert, Prof. Dr. — TUM Klinikum Deutsches Herzzentrum
• Study coordinator: Petra Novakova
• Email: rs.harmonyemeapms@medtronic.com
• Phone: +31612591883

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.