The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study

The primary safety endpoint is point estimate of freedom from procedure or device-related mortality rate at 30 days post procedure.

Defined as:

• Mean RVOT gradient as measured by continuous-wave Doppler ≤40 mmHg -AND-
• Pulmonary regurgitant fraction as measured by magnetic resonance imaging <20%

Technical success at exit from catheterization lab/operating room (OR), as defined as:

• No device- or procedural-related mortality, with
• Successful access, delivery and retrieval of the delivery system, and
• Deployment and correct positioning (including minor repositioning if needed) of the single intended device, and
• No need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure

Device success is defined as:

• No device- or procedural-related mortality, with
• Original intended device in place, and
• No additional surgical or interventional procedures related to access or the device since completion of the original procedure (i.e., exit from the catheterization lab), and
• Intended performance of the device, as defined as:

• Structural performance: No migration, embolization, detachment, major stent fracture, hemolysis, thrombosis, endocarditis, and
• Hemodynamic performance: Relief of insufficiency (PR < moderate) without producing the opposite (mean RVOT gradient > 40 mmHg) as measured by continuous wave Doppler, and
• Absence of para-device complications, as defined by:

• PVL = moderate, or
• Erosion, or
• RVOT or PA rupture

Procedural success is defined as:

• Device success at 30 days, and
• None of the following device- or procedure-related serious adverse events:

• Life-threatening major bleed
• Major vascular or cardiac structural complications required unplanned reintervention or surgery
• Stage 2 or 3 acute kidney injury (AKI) (includes new dialysis)
• Pulmonary embolism
• Severe heart failure (HF) or hypotension requiring IV inotrope, ultrafiltration, or mechanical circulatory support
• Prolonged intubation >48 hours

TPV dysfunction is defined as any one of the following:

• RVOT reoperation for device-related reasons
• Catheter re-intervention of TPV
• Hemodynamic dysfunction of the TPV (moderate or greater pulmonary regurgitation, and/or a mean RVOT gradient >40 mmHg)

All procedure-related serious adverse events. All device-related serious adverse events. Death (all-cause, procedural, and device-related).

Quality of life score over time will be assessed by the SF-36 at pre-implant, 1 month post-implant, 6 months post-implant, 1 year post-implant, 2 years post-implant, and 3 years. The analysis cohort will be the implanted > 24 hours cohort. Minimum score of 0 and maximum score of 100 is possible. Higher values are considered to be a better outcome.

Right ventricle remodeling will be assessed via CMR at pre-implant and 6 months post-implant. The analysis cohort will be implanted longer than 24 hours cohort. The characterization will be made using right ventricular end diastolic volume (ml).

Quality of life score over time will be assessed by the SF-36 at 4 & 5 years. The analysis cohort will be the implanted > 24 hours cohort. Minimum score of 0 and maximum score of 100 is possible. Higher values are considered to be a better outcome.

Right ventricle remodeling will be assessed via CMR at 2 years post- implant and 5 years post-implant. The analysis cohort will be implanted longer than 24 hours cohort. The characterization will be made using right ventricular end diastolic volume (ml).