Actively Recruiting
Harmony TPV EMEA PMS
Led by Medtronic Cardiovascular · Updated on 2026-05-05
80
Participants Needed
12
Research Sites
387 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Harmony TPV EMEA PMS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eligible to receive Harmony TPV System according to Instructions for Use and local regulations
- Able and willing to consent to participate and complete all required follow-up visits
You will not qualify if you...
- Obstruction of the central veins
- Planned branch pulmonary artery stenting at time of implant
- Previously treated with right ventricle to pulmonary artery conduit or implanted bioprosthesis
- Major or progressive non-cardiac disease with life expectancy less than one year (e.g., liver failure, renal failure, cancer)
- Planned Harmony TPV implantation in the left heart
- Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
- Pre-existing prosthetic heart valve or prosthetic ring in any position
- Pregnant females confirmed by positive pregnancy test before implant
- Vulnerable adults or subjects incapable of giving consent, including those with mental incompetence such as Alzheimer's, dementia, psychiatric or developmental disorders, or chromosomal abnormalities with associated cognitive impairment
AI-Screening
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Trial Site Locations
Total: 12 locations
1
Rigshospitalet
Copenhagen, Denmark
Actively Recruiting
2
CHU de Bordeaux - Hôpital Cardiologique du Haut-Leveque
Bordeaux, France, 33600
Actively Recruiting
3
Herz - und Diabeteszentrum NRW
Bad Oeynhausen, Germany
Actively Recruiting
4
Charité - Universitätsmedizin Berlin
Berlin, Germany, 12203
Actively Recruiting
5
Helios Health Institute Standort Leipzig
Leipzig, Germany, 04289
Actively Recruiting
6
TUM University Hospital
Munich, Germany
Actively Recruiting
7
Mater Misericordiae University Hospital
Dublin, Ireland, 7
Actively Recruiting
8
Schneider Children's Medical Center Israel
Petah Tikva, Israel, 49202
Actively Recruiting
9
Policlinico di Sant'Orsola
Bologna, Italy, 40138
Not Yet Recruiting
10
Azienda Ospedaliera di Padova
Padova, Italy
Not Yet Recruiting
11
Hospital General Universitario Gregorio Marañón
Madrid, Spain, 28007
Actively Recruiting
12
Skånes Universitetssjukhus Lund
Lund, Sweden, 22185
Actively Recruiting
Research Team
P
Petra Novakova
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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