An interventional study of Certain imaging assessments can be non-Standard of Care in Severe Pulmonary Valve Regurgitation, sponsored by Medtronic Cardiovascular. Recruiting at 12 sites in 8 countries. Per ClinicalTrials.gov, last updated 2026-07-14.
Sponsored by Medtronic Cardiovascular (part of Medtronic) · Not applicable, Interventional, and Treatment
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.
Prospective, non-randomized, multi-center, post-market interventional clinical study
31 studies on the registry are indexed under Pulmonary Valve Insufficiency; 8 are open to participants now.
This study's planned enrollment of 80 is above the median of 60 across 21 interventional studies indexed under Pulmonary Valve Insufficiency.
Browse Pulmonary Valve Insufficiency studies →Medtronic Cardiovascular is the lead sponsor of 70 studies on the registry; 7 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Subject Consent Section excerpt:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The Harmony TPV implant as per Standard of Care
Radiation: 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.
Proportion of subjects without valve reintervention and with acceptable hemodynamic function composite at 6 months as defined by:
* Mean RVOT gradient as measured by continuous-wave Doppler echocardiography ≤40 mmHg AND * Pulmonary regurgitant fraction as measured by CMR \<20%
Time frame: 6 months
Percentage of subjects free from all-cause mortality at 6-months
Described by Kaplan-Meier statistics at 6-months.
Time frame: 6 months
Percentage of subjects free from reoperation at 6-months
Described by Kaplan-Meier statistics at 6-months
Time frame: 6 months
Percentage of subjects free from catheter reintervention at 6-months
Described by Kaplan-Meier statistics at 6-months.
Time frame: 6 months
Percentage of subjects free from TPV dysfunction at 6-months
Described by Kaplan-Meier statistics at 6-months.
Time frame: 6 months
Number and percentage of subjects with procedure success at 30-days
Time frame: 30 days
Number and percentage of subjects with serious device-related adverse events at 6 months
Also described with Kaplan-Meier method for AEs of clinical interest.
Time frame: 6 months
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jul 2025 (actual). Primary completion is estimated for Jul 2027, 24 months after the start.
How these figures are worked out, and which studies are left out of them.
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Pulmonary Valve Insufficiency →