Harmony TPV EMEA PMS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-30

Study Completion Date

2032-12-31

Brief Summary

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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

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

Conditions

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Severe Pulmonary Valve Regurgitation

Keywords

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Harmony TPV severe pulmonary regurgitation pulmonary valve replacement

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Subjects indicated for the Harmony transcatheter pulmonary heart valve treatment

The Harmony TPV implant as per Standard of Care

Group Type OTHER

Certain imaging assessments can be non-Standard of Care

Intervention Type 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.

Interventions

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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.

Intervention Type RADIATION

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Ewert, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

TUM Klinikum Deutsches Herzzentrum

Locations

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Rigshospitalet

Copenhagen, , Denmark

Site Status RECRUITING

CHU de Bordeaux - Hôpital Cardiologique du Haut-Leveque

Bordeaux, , France

Site Status RECRUITING

Herz - und Diabeteszentrum NRW

Bad Oeynhausen, , Germany

Site Status RECRUITING

Charité - Universitätsmedizin Berlin

Berlin, , Germany

Site Status RECRUITING