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New treatment option for Severe Pulmonary Valve Regurgitation
Official title Harmony TPV EMEA PMS
ClinicalTrials.gov ID: NCT06906926
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- 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...
You likely can't join if
- Obstruction of the central veins.
- Planned concomitant branch pulmonary artery stenting at time of implant.
- people 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.
See the full eligibility 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
- Obstruction of the central veins.
- Planned concomitant branch pulmonary artery stenting at time of implant.
- people 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 people of childbearing potential.
- people that are vulnerable as defined in the Section 10.5 Subject Consent Subject Consent Section excerpt:
- Vulnerable adults, defined as people 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...
The study team makes the final eligibility decision.
Where it's taking place
- Copenhagen, Denmark
- Bordeaux, France
- Bad Oeynhausen, Germany
- Berlin, Germany
- Leipzig, Germany
- Munich, Germany
- Dublin, Ireland
- Petah Tikva, Israel
- Bologna, Italy
- Padova, Italy
- Madrid, Spain
- Lund, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Copenhagen, Denmark; Bordeaux, France; Bad Oeynhausen, Germany; Berlin, Germany; Leipzig, Germany; Munich, Germany and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.