Clinical trial NCT06906926: Harmony TPV EMEA PMS
Official title: Harmony TPV EMEA Post-Market Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Severe Pulmonary Valve Regurgitation
Keywords: Harmony TPV
severe pulmonary regurgitation
pulmonary valve replacement
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2025-04-02
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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

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.

Primary outcomes:
measure: Proportion of subjects without valve reintervention and with acceptable hemodynamic function composite at 6 months as defined by:
timeFrame: 6 months
Secondary outcomes:
measure: Percentage of subjects free from all-cause mortality at 6-months
timeFrame: 6 months
measure: Percentage of subjects free from reoperation at 6-months
timeFrame: 6 months
measure: Percentage of subjects free from catheter reintervention at 6-months
timeFrame: 6 months
measure: Percentage of subjects free from TPV dysfunction at 6-months
timeFrame: 6 months
measure: Number and percentage of subjects with procedure success at 30-days
timeFrame: 30 days
measure: Number and percentage of subjects with serious device-related adverse events at 6 months
timeFrame: 6 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Bordeaux
country: France
facility: CHU de Bordeaux - Hôpital Cardiologique du Haut-Leveque
city: Bad Oeynhausen
country: Germany
facility: Herz - und Diabeteszentrum NRW
city: Berlin
country: Germany
facility: Deutsches Herzzentrum der Charité
city: Munich
country: Germany
facility: Deutsches Herzzentrum München
city: Dublin
country: Ireland
facility: Mater Misericordiae University Hospital
city: Petah Tikva
country: Israel
facility: Schneider Children's Medical Center Israel
city: Bologna
country: Italy
facility: Policlinico di Sant'Orsola
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Lund
country: Sweden
facility: Skånes Universitetssjukhus Lund
Study officials:
affiliation: TUM Klinikum Deutsches Herzzentrum
name: Peter Ewert, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: