Post-market registry for post-market surveillance, as part of the post-market plan, for the HighLife transcatheter, transseptal, mitral valve replacement system in a real world commercial setting.
Study Type
OBSERVATIONAL
Enrollment
150
Universitätsklinikum Ulm
Ulm, Ulm, Germany
Rate of Technical Success
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
Time frame: At exit from procedure room
Rate of Device Success
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
Time frame: 30 days
Primary Performance Endpoint
Rate of Total Mitral Regurgitation reduction to 1+ or less assessed by transthoracic echo (TTE), and as analyzed by an independent Core Lab
Time frame: 30 days
Procedural Mortality
Where patient died during the procedure before exiting the procedure room
Time frame: At exit from the procedure room
All-cause mortality
Patient death due to any cause
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Time frame: 30 days, 6 months, 12 months, 1, 2, and 3 year
Reoperation
To include conversion to surgery, reintervention to surgery or non-surgical procedure
Time frame: 30 days
Disabling stroke
Meeting the criteria of disabling versus non-disabling stroke, as defined per MVARC guidelines, to include if ischemic or hemorrhagic
Time frame: 30 days, 6 months, 1, 2, 3 years
New onset conduction disturbance in the heart
This would be a heart conduction disturbance requiring a permanent pacemaker
Time frame: 30 days
Heart Failure Hospitalization
This would be a heart failure hospitalization, defined per the MVARC guidelines.
Time frame: 30 days, 6 and 12 months, 1, 2, 3 years
Freedom from left ventricular outflow tract obstruction (LVOTO)
Mean LVOT gradient ≥ 10 mmHg, as measured by transthoracic echo (TTE), and as analyzed by an independent Core Lab
Time frame: 30 days
Freedom from paravalvular leak (PVL), > 1+
This would be a leak around the HighLife valve, as assessed by transthoracic echo (TTE), and analyzed by an independent Core Lab
Time frame: 30 days
Annualized rate of Heart Failure Hospitalization (HFH)
An analysis performed by the biostatistician, to evaluate how often a patient experienced HFH in a year.
Time frame: 1, 2, 3 years
Total reduction of mitral regurgitation (MR) to 1+ or less
Measure by transthoracic echo (TTE), and as analyzed by an independent Core Lab
Time frame: 30 days, 6 months, 1, 2, 3 years
Long term durability of the HighLife valve
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).
Time frame: 3 years
KCCQ score (mean) improvement
Mean improvement in the KCCQ Quality of Life Questionnaire (short form), comparing Baseline to 1 year
Time frame: 1 year
Improvement in six minute walk test (6MWT)
Measuring the number of meters a patient can walk in 6 minutes, comparing Baseline to 1 year
Time frame: 1 year