NCT06906926RecruitingNot Applicable
Harmony TPV EMEA Post-Market Study
Medtronic Cardiovascular23 sites in 8 countries80 target enrollmentStarted: July 30, 2025Last updated:
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 80
- Locations
- 23
- Primary Endpoint
- Proportion of subjects without valve reintervention and with acceptable hemodynamic function composite at 6 months as defined by:
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Arms & Interventions
Subjects indicated for the Harmony transcatheter pulmonary heart valve treatment
Other
The Harmony TPV implant as per Standard of Care
Intervention: Certain imaging assessments can be non-Standard of Care (Radiation)
Outcomes
Primary Outcomes
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%
Secondary Outcomes
- Number and percentage of subjects with serious device-related adverse events at 6 months(6 months)
- Percentage of subjects free from catheter reintervention at 6-months(6 months)
- 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 TPV dysfunction at 6-months(6 months)
- Number and percentage of subjects with procedure success at 30-days(30 days)
Investigators
Study Sites (23)
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