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NCT06906926 | NOT YET RECRUITING | Severe Pulmonary Valve Regurgitation

Harmony TPV EMEA PMS
Sponsor:

Medtronic Cardiovascular

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.

Condition or disease

Severe Pulmonary Valve Regurgitation

Intervention/treatment

Certain imaging assessments can be non-Standard of Care

Phase

NA

Detailed Description:

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

Study Type : INTERVENTIONAL
Estimated Enrollment : 80 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Harmony TPV EMEA Post-Market Study
Actual Study Start Date : 2025-06-01
Estimated Primary Completion Date : 2027-07-31
Estimated Study Completion Date : 2032-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study:
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
Harmony TPV EMEA PMS

Location Details

NCT06906926

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Denmark,

Rigshospitalet

Copenhagen, Denmark,

Not yet recruiting

Germany,

Heart and Diabetes Center NRW

Bad Oeynhausen, Germany,

Not yet recruiting

Germany,

German Heart Center of the Charité

Berlin, Germany, 12203

Not yet recruiting

Germany,

German Heart Center Munich

Munich, Germany,

Not yet recruiting

Israel,

Schneider Children's Medical Center Israel

Heels of a tip, Israel, 49202

Not yet recruiting

Italy,

Hospital of Padua

Padova, Italy,

Not yet recruiting

Spain,

Gregorio Marañón University General Hospital

Madrid, Spain, 28007

Not yet recruiting

Sweden,

Skåne University Hospital Lund

Lund, Sweden, 22185