Harmony TPV EMEA PMS

May 4, 2026 updated by: Medtronic Cardiovascular

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Subjects indicated for the Harmony transcatheter pulmonary heart valve treatment
The Harmony TPV implant as per Standard of Care
Radiation: Certain imaging assessments can be non-Standard of Care
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of subjects free from all-cause mortality at 6-months
Time Frame: 6 months
Described by Kaplan-Meier statistics at 6-months.
6 months
Percentage of subjects free from catheter reintervention at 6-months
Time Frame: 6 months
Described by Kaplan-Meier statistics at 6-months.
6 months
Percentage of subjects free from TPV dysfunction at 6-months
Time Frame: 6 months
Described by Kaplan-Meier statistics at 6-months.
6 months
Number and percentage of subjects with serious device-related adverse events at 6 months
Time Frame: 6 months
Also described with Kaplan-Meier method for AEs of clinical interest.
6 months
Percentage of subjects free from reoperation at 6-months
Time Frame: 6 months
Described by Kaplan-Meier statistics at 6-months
6 months
Number and percentage of subjects with procedure success at 30-days
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiovascular

Investigators

  • Principal Investigator: Peter Ewert, Prof. Dr., TUM Klinikum Deutsches Herzzentrum

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2025

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

December 31, 2032

Study Registration Dates

First Submitted

March 26, 2025

First Submitted That Met QC Criteria

March 26, 2025

First Posted (Actual)

April 2, 2025

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDT23033CON005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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