The EMBRACE Registry: European Post-Market Registry for Catheter Based Mitral Valve Replacement

To measure the rate of subjects that meet the definition of Technical success defined as an alive participant at exit from procedure room, with all of the following:

• Successful vascular access, delivery and retrieval of the HighLife delivery systems
• Deployment and correct positioning of the HighLife 28mm bio-prosthesis
• Freedom from additional emergency surgery or re-intervention related to the device or access procedure, that occurred (was initiated) during the procedure

To measure the rate of subjects that meet the definition of Device safety, defined as the freedom of major adverse events at 30 days, as follows:

• All-cause mortality
• Myocardial infarction
• Major/disabling stroke
• Life-threatening bleeding (MVARC scale)
• Major access and vascular complications
• Stage 2 or 3 acute kidney injury (includes dialysis)
• Any mitral valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention
• Severe hypotension, heart failure or respiratory failure requiring intravenous vasopressors or invasive or mechanical heart failure treatments such as ultrafiltration or hemodynamic assist devices, including intra-aortic balloon pumps or left ventricular or biventricular assist devices for ≥ 48 hours, or prolonged intubation for ≥ 48 hours

Rate of Total Mitral Regurgitation reduction to 1+ or less assessed by transthoracic echo (TTE), and as analyzed by an independent Core Lab

Where patient died during the procedure before exiting the procedure room

Patient death due to any cause

To include conversion to surgery, reintervention to surgery or non-surgical procedure

Meeting the criteria of disabling versus non-disabling stroke, as defined per MVARC guidelines, to include if ischemic or hemorrhagic

This would be a heart conduction disturbance requiring a permanent pacemaker

This would be a heart failure hospitalization, defined per the MVARC guidelines.

Mean LVOT gradient ≥ 10 mmHg, as measured by transthoracic echo (TTE), and as analyzed by an independent Core Lab

This would be a leak around the HighLife valve, as assessed by transthoracic echo (TTE), and analyzed by an independent Core Lab

An analysis performed by the biostatistician, to evaluate how often a patient experienced HFH in a year.

Measure by transthoracic echo (TTE), and as analyzed by an independent Core Lab

That the original HighLife device remains implanted, free from structural valve dysfunction (e.g. residual MR ≥2+ in the presence of morphological deterioration (e.g., torn, flail, or frozen leaflet, calcification, fracture, migration or embolization, device detachment), as assessed by transthoracic echo (TTE) and analyzed by an independent Core Lab, or as adjudicated by a Clinical Events Committee (CEC).

Mean improvement in the KCCQ Quality of Life Questionnaire (short form), comparing Baseline to 1 year

Measuring the number of meters a patient can walk in 6 minutes, comparing Baseline to 1 year