Harmony TPV EMEA PMS

Covidien

Status: Begins enrollment in 1 month

Conditions: Severe Pulmonary Valve Regurgitation

Treatments: Radiation: Certain imaging assessments can be non-Standard of Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT06906926

MDT23033CON005

Details and patient eligibility

About

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.

Full description

Prospective, non-randomized, multi-center, post-market interventional clinical study

Enrollment: 80 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

80 participants in 1 patient group

Subjects indicated for the Harmony transcatheter pulmonary heart valve treatment

Other group

Description:

The Harmony TPV implant as per Standard of Care

Treatment:

Radiation: Certain imaging assessments can be non-Standard of Care