Harmony TPV EMEA PMS
ConditionSevere Pulmonary Valve Regurgitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorMedtronic Cardiovascular
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Certain imaging assessments can be non-Standard of Care
RadiationPre-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.
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: Subjects indicated for the Harmony transcatheter pulmonary heart valve treatmentOther 1 intervention
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
Percentage of subjects free from all-cause mortality at 6-months
Described by Kaplan-Meier statistics at 6-months.
Time frame
6 months2
Percentage of subjects free from reoperation at 6-months
Described by Kaplan-Meier statistics at 6-months
Time frame
6 months3
Percentage of subjects free from catheter reintervention at 6-months
Described by Kaplan-Meier statistics at 6-months.
Time frame
6 months4
Percentage of subjects free from TPV dysfunction at 6-months
Described by Kaplan-Meier statistics at 6-months.
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov