This study will evaluate the safety and performance of the ADAPT 3D - ALR in adult patients requiring replacement of aortic valve. 15 patients in one site in Belgium will all be treated with ADAPT 3D - ALR.
The purpose of this study is to conduct the initial clinical investigation of single piece ADAPT treated 3D - ALR (Aortic Leaflet Repair) to collect evidence on the device's safety and performance. The study is anticipated to confirm successful clinical safety and clinical performance with significant improvements in clinical hemodynamic performance. The ADAPT® technology is used to process animal derived tissues to produce implantable tissue prosthetic devices that are compatible with the human body. This technology has been shown to produce reliable, biocompatible and versatile regenerative prosthetic devices capable of being used instead of synthetic products currently used in many soft tissue repair applications. 15 patients with aortic valve insufficiency or stenosis will be enrolled in this single arm single site study. Follow-up will continue through to 26 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
The operation is performed through a median sternotomy and with the hemodynamic support of standard cardiopulmonary bypass (CBP). diseased leaflets are excised meticulously. Calcifications at the level of the annulus will be removed just like in any other aortic valve replacement procedure. The annulus will be sized and the appropriate 3D single piece valve will be chosen. The implant technique will consist out of one running suture line at the level of the annulus, followed by fixation of the 3 commissural parts against the aortic wall. Valve competence and function will be assessed visually, and by TEE immediately coming of bypass.
University Hospital Leuven
Leuven, Belgium
RECRUITINGmean pressure gradient (mmHg) across the valve (less than 20 mmHg)
Hemodynamic Performance Assessment
Time frame: 6 months following implantation
derived Effective Orifice Area (EOA) range > 0.9 cm2 (19mm valve) to > 1.6 cm2 (27mm valve)
Hemodynamic Performance Assessment
Time frame: 6 months following implantation
rate of thromboembolism
The adverse events consistent with the Objective Performance Criteria (OPC), for flexible heart valves will be compared to those rates defined as acceptable levels in the standard.
Time frame: 6 months following implantation
rate of valve thrombosis
The adverse events consistent with the Objective Performance Criteria (OPC), for flexible heart valves will be compared to those rates defined as acceptable levels in the standard.
Time frame: 6 months following implantation
rate of major paravalvular leak
The adverse events consistent with the Objective Performance Criteria (OPC), for flexible heart valves will be compared to those rates defined as acceptable levels in the standard.
Time frame: 6 months following implantation
rate of major hemorrhage
The adverse events consistent with the Objective Performance Criteria (OPC), for flexible heart valves will be compared to those rates defined as acceptable levels in the standard.
Time frame: 6 months following implantation
rate of endocarditis
The adverse events consistent with the Objective Performance Criteria (OPC), for flexible heart valves will be compared to those rates defined as acceptable levels in the standard.
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Time frame: 6 months following implantation
Rate of Atrial Fibrillation 6 months post procedure
New/post-operative atrial fibrillation - confirmed on ECG after closure till 6 months
Time frame: 6 months post procedure
number of days in ICU
Length of stay in the ICU post valve implantation defined as arrival time/date in hours and minutes to transfer to ward time/date in hours and minutes.
Time frame: 30 days post procedure
NYHA (New York Heart Association) class Improvement Assessment
Clinically significant improvement (one grade) in the New York Heart Association (NYHA) functional classification. 4 classes of disease: min value Class IV (cardiac disease resulting in inability to carry on any physical activity without discomfort); max value Class I (cardiac disease but without resulting limitations of physical activity)
Time frame: 6 months post procedure
number of days in hospital post procedure
Post procedure length of stay defined as the date and time in hours and minutes documented for arrival in the recovery unit to date and time in hours and minutes of discharge in hours and minutes.
Time frame: 30 days post procedure
hemoglobin assessment
Hemolysis screen measured by blood test
Time frame: 6 months post procedure
Alanine transaminase (ALT)
Hemolysis screen measured by blood test of liver enzyme
Time frame: 6 months post procedure
Aspartate transaminase (AST)
Hemolysis screen measured by blood test of liver enzyme
Time frame: 6 months post procedure
Rate of all-caused death
The rate will be compared to clinical outcomes for surgically implanted heart valves reported in the literature.
Time frame: 6 months following implantation
Rate of valve related death
The rate will be compared to clinical outcomes for surgically implanted heart valves reported in the literature.
Time frame: 6 months following implantation
Rate of valve-related reoperation
The rate will be compared to clinical outcomes for surgically implanted heart valves reported in the literature.
Time frame: 6 months following implantation
Rate of valve explant
The rate will be compared to clinical outcomes for surgically implanted heart valves reported in the literature.
Time frame: 6 months following implantation
Rate of hemorrhage
The rate will be compared to clinical outcomes for surgically implanted heart valves reported in the literature.
Time frame: 6 months following implantation
Rate of all-cause reoperation
The rate will be compared to clinical outcomes for surgically implanted heart valves reported in the literature.
Time frame: 6 months following implantation
Rate of Device deficiency
Device deficiency measured by echo
Time frame: 6 months following implantation