Harmony TPV Post-Approval Study (NCT05077774) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Harmony TPV Post-Approval Study
United States150 participantsStarted 2021-10-25
Plain-language summary
The purpose of this study is to characterize the functionality of transcatheter implantation of the Medtronic Harmony Transcatheter Pulmonary Valve (TPV) achieved by real-world implanters.
Who can participate
SexALL
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Inclusion Criteria:
* Patient eligible to receive the Harmony TPV, meeting the indications for use criteria per current geography-specific device labeling at time of study enrollment
* Patient (or patient's legally authorized representative) is willing to consent to participate in the study
Exclusion Criteria:
* Obstruction of the central veins
* Planned concomitant branch pulmonary artery stenting at time of implant
* Subject is pregnant at time of implant procedure
* Patients with 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
What they're measuring
1
Proportion of subjects without valve reintervention and with acceptable hemodynamic function composite at 6 months as defined by: