Severe Pulmonary Valve RegurgitationNCT06906926
Harmony TPV EMEA PMS
A study of Severe Pulmonary Valve Regurgitation, run by Medtronic Cardiovascular at 12 sites in 8 countries.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Severe Pulmonary Valve Regurgitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 12 sitesin 8 countries
- Study dates
- 30 Jul 2025to 31 Dec 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
12 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
12 sites in 8 countries
Germany4 sites, 4 recruiting
- Recruiting
Herz - und Diabeteszentrum NRW
Bad Oeynhausen
Stephan Schubert, Prof. Dr., sschubert@hdz-nrw.de
- Recruiting
Charité - Universitätsmedizin Berlin
Berlin, 12203
Peter Kramer, Dr., peter.kramer@dhzc-charite.de
- Recruiting
Helios Health Institute Standort Leipzig
Leipzig, 04289
Ingo Dähnert, Prof. Dr., Ingo.Daehnert@helios-gesundheit.de
- Recruiting
TUM University Hospital
Munich
Peter Ewert, Prof. Dr., ewert@dhm.mhn.de
Italy2 sites, 2 recruiting
- Recruiting
Policlinico di Sant'Orsola
Bologna, 40138
Andrea Donti, Dr., andrea.donti@aosp.bo.it
- Not yet recruiting
Azienda Ospedaliera di Padova
Padova
Biagio Castaldi, Prof., biagio.castaldi@aopd.veneto.it
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen
Michael Rahbek Schmidt, Dr., michael.rahbek.schmidt@regionh.dk
France1 site, 1 recruiting
- Recruiting
CHU de Bordeaux - Hôpital Cardiologique du Haut-Leveque
Bordeaux, 33600
Jean-Benoit Thambo, Dr., jean-benoit.thambo@chu-bordeaux.fr
Ireland1 site, 1 recruiting
- Recruiting
Mater Misericordiae University Hospital
Dublin, 7
Damien Kenny, Prof. Dr., Damien.Kenny@childrenshealthireland.ie
Israel1 site, 1 recruiting
- Recruiting
Schneider Children's Medical Center Israel
Petah Tikva, 49202
Einat Birk, Prof., ebirk@clalit.org.il
Spain1 site, 1 recruiting
- Recruiting
Hospital General Universitario Gregorio Marañón
Madrid, 28007
Ricardo Sanz, Dr., ricardo.sanz@salud.madrid.org
Sweden1 site, 1 recruiting
- Recruiting
Skånes Universitetssjukhus Lund
Lund, 22185
Petru Liuba, Prof., petru.liuba@med.lu.se
About this study
Official title: Harmony TPV EMEA Post-Market Study
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.
Read the detailed description
Prospective, non-randomized, multi-center, post-market interventional clinical study
- Conditions
- Severe Pulmonary Valve Regurgitation
- Being tested
- Certain imaging assessments can be non-Standard of Care
- Keywords
- Harmony TPV, severe pulmonary regurgitation, pulmonary valve replacement
- Medical subject headings
- Pulmonary Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Certain imaging assessments can be non-Standard of CareRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Subjects indicated for the Harmony transcatheter pulmonary heart valve treatment | Other | The Harmony TPV implant as per Standard of Care Receives: Radiation: Certain imaging assessments can be non-Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: 6 months
Secondary outcomes (6)
Percentage of subjects free from all-cause mortality at 6-months
Described by Kaplan-Meier statistics at 6-months.
Measured: 6 months
Percentage of subjects free from reoperation at 6-months
Described by Kaplan-Meier statistics at 6-months
Measured: 6 months
Percentage of subjects free from catheter reintervention at 6-months
Described by Kaplan-Meier statistics at 6-months.
Measured: 6 months
Percentage of subjects free from TPV dysfunction at 6-months
Described by Kaplan-Meier statistics at 6-months.
Measured: 6 months
Number and percentage of subjects with procedure success at 30-days
Measured: 30 days
Number and percentage of subjects with serious device-related adverse events at 6 months
Also described with Kaplan-Meier method for AEs of clinical interest.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start30 Jul 2025
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Pulmonary Valve RegurgitationStudies of the same condition, open and under way.
- More trials run by Medtronic CardiovascularThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Ewert, Prof. Dr., Principal investigator, TUM Klinikum Deutsches Herzzentrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06906926
- Sponsor's protocol ID
- MDT23033CON005
- Status last verified
- Jul 2026
- First submitted
- 26 Mar 2025
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harmony TPV EMEA Post-Market Study
- ClinicalTrials.gov ID
- NCT06906926
- Acronym / sponsor ID
- MDT23033CON005
- Conditions
- Severe Pulmonary Valve Regurgitation
- Keywords
- Harmony TPV, severe pulmonary regurgitation, pulmonary valve replacement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Medtronic CardiovascularIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 2 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects indicated for the Harmony transcatheter pulmonary heart valve treatment | Other | Radiation: Certain imaging assessments can be non-Standard of CareThe Harmony TPV implant as per Standard of Care |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Certain imaging assessments can be non-Standard of CarePre-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. | Radiation | Subjects indicated for the Harmony transcatheter pulmonary heart valve treatment |
Primary outcome
Proportion of subjects without valve reintervention and with acceptable hemodynamic function composite at 6 months as defined by:
Time frame: 6 months
* Mean RVOT gradient as measured by continuous-wave Doppler echocardiography ≤40 mmHg AND * Pulmonary regurgitant fraction as measured by CMR <20%
6 secondary outcomes
Percentage of subjects free from all-cause mortality at 6-months
Time frame: 6 months
Percentage of subjects free from reoperation at 6-months
Time frame: 6 months
Percentage of subjects free from catheter reintervention at 6-months
Time frame: 6 months
Percentage of subjects free from TPV dysfunction at 6-months
Time frame: 6 months
Number and percentage of subjects with procedure success at 30-days
Time frame: 30 days
Number and percentage of subjects with serious device-related adverse events at 6 months
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Severe Pulmonary Valve Regurgitation
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TRICuspid Intervention and Invasive Hemodynamic Monitoring in Heart Failure
Heart Failure With Severe Tricuspid Regurgitation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter Ewert, Prof. Dr. principal investigator
TUM Klinikum Deutsches Herzzentrum
12 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Severe Pulmonary Valve Regurgitation, run by Medtronic Cardiovascular at 12 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Germany, Italy, Denmark, France, Ireland and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Petra Novakova (+31612591883, rs.harmonyemeapms@medtronic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects without valve reintervention and with acceptable hemodynamic function composite at 6 months as defined by: (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.