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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Harmony Transcatheter Pulmonary Valve (sizes 22 mm and 25 mm) and Harmony Delivery Catheter System (DCS)
University of Alabama at Birmingham Hospital
Birmingham, Alabama, United States
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
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