Harmony TPV EMEA PMS

NCT06906926 | Recruiting FDA Device

• 1 other identifier: MDT23033CON005
• Study Type: interventional
• Target: 80
• Locations: 8 countries
• Sites: 12

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.

Conditions

Severe Pulmonary Valve Regurgitation

Keywords

Harmony TPV; severe pulmonary regurgitation; pulmonary valve replacement

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects without valve reintervention and with acceptable hemodynamic function composite at 6 months as defined by:

  * Mean RVOT gradient as measured by continuous-wave Doppler echocardiography ≤40 mmHg AND * Pulmonary regurgitant fraction as measured by CMR \<20%

  6 months

Secondary Outcomes (6)

• Percentage of subjects free from all-cause mortality at 6-months

  6 months

• Percentage of subjects free from reoperation at 6-months

  6 months

• Percentage of subjects free from catheter reintervention at 6-months

  6 months

• Percentage of subjects free from TPV dysfunction at 6-months

  6 months

• Number and percentage of subjects with procedure success at 30-days

  30 days

Study Arms (1)

Subjects indicated for the Harmony transcatheter pulmonary heart valve treatment

OTHER

The Harmony TPV implant as per Standard of Care

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

Interventions

Certain imaging assessments can be non-Standard of Care RADIATION

Pre-Implant CT, Chest X-Ray at discharge and any related assessments during the following up visit, can be non-standard of care depending on site's / countries.

Subjects indicated for the Harmony transcatheter pulmonary heart valve treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject eligible to receive Harmony TPV System in conformity with Instructions for Use (IFU) and local regulations at time of study enrollment.
• 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

You may not qualify if:

• Obstruction of the central veins.
• Planned concomitant branch pulmonary artery stenting at time of implant.
• Subjects previously treated with an RV-PA conduit or previously implanted bioprosthesis.
• 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.
• Planned implantation of the Harmony TPV in the left heart.
• Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
• Pre-existing prosthetic heart valve or prosthetic ring in any position
• Subject is pregnant as confirmed by a positive pregnancy test before implant procedure for female subjects of childbearing potential.
• 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.

Sponsors & Collaborators

• Medtronic Cardiovascular: lead

Study Sites (12)

Rigshospitalet

Copenhagen, Denmark

RECRUITING

CHU de Bordeaux - Hôpital Cardiologique du Haut-Leveque

Bordeaux, 33600, France

RECRUITING

Herz - und Diabeteszentrum NRW

Bad Oeynhausen, Germany

RECRUITING

Charité - Universitätsmedizin Berlin

Berlin, 12203, Germany

RECRUITING

Helios Health Institute Standort Leipzig

Leipzig, 04289, Germany

RECRUITING

TUM University Hospital

Munich, Germany

RECRUITING

Mater Misericordiae University Hospital

Dublin, 7, Ireland

RECRUITING

Schneider Children's Medical Center Israel

Petah Tikva, 49202, Israel

RECRUITING

Policlinico di Sant'Orsola

Bologna, 40138, Italy

NOT YET RECRUITING

Azienda Ospedaliera di Padova

Padova, Italy

NOT YET RECRUITING

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

RECRUITING

Skånes Universitetssjukhus Lund

Lund, 22185, Sweden

RECRUITING

MeSH Terms

Conditions

Pulmonary Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Peter Ewert, Prof. Dr.

  TUM Klinikum Deutsches Herzzentrum

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Petra Novakova

CONTACT

+31612591883; rs.harmonyemeapms@medtronic.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 2, 2025
• Study Start: July 30, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): December 31, 2032
• Last Updated: May 5, 2026

Record last verified: 2026-05

Locations

SE (1); IT (2); DK (1); DE (4); ES (1); IE (1); IL (1); FR (1)