The purpose is to evaluate the safety, effectiveness and performance of Venus-Vitae Transcatheter Heart Valve System in patients with severe aortic stenosis.
This trial is a prospective, multi-center, non-randomized interventional study to evaluate the safety, effectiveness and performance of the Venus-Vitae Transcatheter Heart Valve System in patients with severe aortic stenosis. Clinical visits will be scheduled at screening, pre-discharge, 30 days, 6 months, 12 months and annually thereafter to 5 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
The Venus-Vitae THV is comprised of balloon-expandable and radiopaque cobalt-chromium alloy frame, porcine pericardium tri-leaflet, porcine pericardium inner skirt, polyurethane outer skirt, PTFE assembly sutures, and three radiopaque gold markers (Figure 1). The valve utilizes Venus Endura technology and stored in a non-aqueous condition.
The rate of deaths at the one-year follow-up visit post procedure
All-cause mortality (The rate of deaths at the one-year follow-up visit post procedure)
Time frame: 1 Years
Acceptable Hemodynamic Performance at 30 days
Acceptable Bio-prosthesis Hemodynamic Performance at 30 days, defined as: * Mean gradient \< 20mmHg * Less than moderate aortic regurgitation (perivalvular and transvalvular)
Time frame: 30 Days
Occurrence of the following adverse events echocardiogram during follow-up
Occurrence of the following adverse events echocardiogram during follow-up (The rate of follow events during the follow-up) * All-cause mortality * All stroke * Life-threatening bleeding * Acute MI * Heart failure hospitalizations * New permanent pacemaker implantation * Major vascular complication * Acute kidney injury * Aortic valve re-intervention (surgical or transcatheter) * Valve thrombosis * Structural valve deterioration
Time frame: 5 Years
Technical success is defined as the following
Technical success (at exit from procedure room) (VARC-3\[1\]) (The rate of Technical success at the Procedure) * Freedom from mortality * Successful access, delivery of the device, and retrieval of the delivery system * Correct positioning of a single prosthetic heart valve into the proper anatomical location * Freedom from surgery or intervention related to the device or a major vascular or access-related, or cardiac structural complication
Time frame: During the Procedure
The rate of device success is defined as the following
Device success (in-hospital) (VARC-3\[1\]) (The rate of device success during the in-hospital) * Freedom from mortality * Freedom from surgery or intervention related to the device or a major vascular or access-related or cardiac structural complication * Intended performance of the valve (mean gradient \< 20 mmHg, peak velocity \<3 m/s, and less than moderate aortic regurgitation)
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Time frame: Up to 1 week
The rate of acceptable valve function at pre-discharge by echocardiogram defined as the following:
Acceptable valve function at pre-discharge by echocardiogram (The rate of follow events during the follow-up) * Freedom from moderate or greater patient-prosthesis mismatch (PPM) * MPG \<20mmHg * Freedom from moderate or greater regurgitation (transvalvular and paravalvular) * Freedom from reoperation or intervention
Time frame: Up to 1 week
The rate of freedom from severe coronary overlap assessed by post-implant angiogram
Freedom from severe coronary overlap assessed by post-implant angiogram
Time frame: immediately after the procedure
The rate of freedom from mild or greater commissure misalignment assessed by post-implant angiogram and/or 30-day CT
Freedom from mild or greater commissure misalignment assessed by post-implant angiogram and/or 30-day CT (post-implant 30-day CT scan is not mandatory for each subjects)
Time frame: 30-Days
The rate of freedom from mild or greater PVL by echocardiogram during follow-up
Freedom from mild or greater PVL by echocardiogram during follow-up
Time frame: 5 Years
New York Heart Association (NYHA) classification during follow-up
New York Heart Association (NYHA) classification during follow-up
Time frame: 5 Years