Severe Pulmonary Valve Regurgitation
Conditions
Keywords
Harmony TPV, severe pulmonary regurgitation, pulmonary valve replacement
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.
Detailed description
Prospective, non-randomized, multi-center, post-market interventional clinical study
Interventions
RADIATIONCertain 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.
Sponsors
Medtronic Cardiovascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects without valve reintervention and with acceptable hemodynamic function composite at 6 months as defined by: | 6 months | * Mean RVOT gradient as measured by continuous-wave Doppler echocardiography ≤40 mmHg AND * Pulmonary regurgitant fraction as measured by CMR \<20% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of subjects free from all-cause mortality at 6-months | 6 months | Described by Kaplan-Meier statistics at 6-months. |
| Percentage of subjects free from reoperation at 6-months | 6 months | Described by Kaplan-Meier statistics at 6-months |
| Percentage of subjects free from catheter reintervention at 6-months | 6 months | Described by Kaplan-Meier statistics at 6-months. |
| Percentage of subjects free from TPV dysfunction at 6-months | 6 months | Described by Kaplan-Meier statistics at 6-months. |
| Number and percentage of subjects with procedure success at 30-days | 30 days | — |
| Number and percentage of subjects with serious device-related adverse events at 6 months | 6 months | Also described with Kaplan-Meier method for AEs of clinical interest. |
Countries
Denmark, France, Germany, Ireland, Israel, Italy, Spain, Sweden
Contacts
CONTACTPetra Novakova
PRINCIPAL_INVESTIGATORPeter Ewert, Prof. Dr.
TUM Klinikum Deutsches Herzzentrum
Outcome results
None listed