The purpose of this study is to evaluate the safety and performance of the HLT System in patients with severe aortic stenosis who present at High Risk for aortic valve replacement surgery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Transcatheter aortic valve replacement with an HLT Transcatheter Aortic Valve System
University of Leipzig - Heart Center
Leipzig, Germany
Primary Performance Endpoint 1: Procedural Device Performance
The primary performance endpoint is the Device Success defined as: * Absence of procedural mortality AND * Correct positioning of a single HLT Valve into the proper anatomical location AND * Intended performance of the HLT Valve (no prosthesis- patient mismatch and mean aortic valve gradient \< 20 mmHg or peak aortic valve velocity \< 3 m/sec, AND no moderate or severe aortic valve regurgitation)
Time frame: Post procedure (day of procedure)
Primary Safety Endpoint 2: Mortality at 30 days
The primary safety endpoint is all-cause mortality at 30 days.
Time frame: 30 days
Secondary Performance Endpoint 1: Post-procedural Valve Performance
The HLT Valve performance will be evaluated by the following parameters with echocardiograms obtained at pre-discharge, 1, 6, 12, 24, 36, 48 and 60 months: * Aortic valve effective orifice area (EOA) * Severity of aortic valve regurgitation (AR) * Aortic valve gradient
Time frame: pre-discharge (up to 14 days), 1, 6, 12, 24, 36, 48 and 60 months
Secondary Safety Endpoint 2: Adverse Events
All adverse events will be assessed throughout the 5 year follow up period
Time frame: throughout the 5 year follow up period
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