Harmony TPV EMEA PMS

Launched by MEDTRONIC CARDIOVASCULAR · Mar 26, 2025

Keywords

ClinConnect Summary

The Harmony TPV EMEA PMS clinical trial is studying a new treatment for individuals with severe pulmonary valve regurgitation, a condition affecting the heart's ability to pump blood effectively. This trial will evaluate the Harmony Transcatheter Pulmonary Valve (TPV) System, which is designed for both children and adults with congenital heart disease who need a replacement for their pulmonary valve due to this condition. Participants will be selected based on specific medical guidelines, and they must be able to give their consent or have a guardian who can.

To be eligible for the trial, participants must have certain heart conditions and should not have other significant health issues that could affect their participation. The study is not yet recruiting, but those who join can expect a thorough follow-up process to monitor their health after receiving the valve. It’s important to note that individuals with specific heart blockages, certain previous treatments, or other serious illnesses may not qualify for this trial. Overall, this research aims to improve treatment options for those with pulmonary valve issues, potentially leading to better health outcomes.

Gender

ALL

Eligibility 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.