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| Name | Class |
|---|---|
| Factory CRO for Medical Devices B.V. | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADAPT 3D ALR | Experimental | Patients treated with ADAPT 3D ALR |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantation of ADAPT 3D ALR | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| mean pressure gradient (mmHg) across the valve (less than 20 mmHg) | Hemodynamic Performance Assessment | 6 months following implantation |
| derived Effective Orifice Area (EOA) range > 0.9 cm2 (19mm valve) to > 1.6 cm2 (27mm valve) | Hemodynamic Performance Assessment | 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. | 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. | 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. | 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. | 6 months following implantation |
| rate of endocarditis |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Atrial Fibrillation 6 months post procedure | New/post-operative atrial fibrillation - confirmed on ECG after closure till 6 months | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Factory CRO | Contact | +31 30 229 2727 | jurriaan.sombeek@avaniaclinical.com | |
| Deanna Linden | Contact | +1 651 493 0606 | 1012 | dlinden@anteristech.com |
| Name | Affiliation | Role |
|---|---|---|
| Bart Meuris, Prof. Dr. | Universitaire Ziekenhuizen KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Leuven | Recruiting | Leuven | 3000 | Belgium |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D001022 | Aortic Valve Insufficiency |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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prospective, non-randomised, single arm, single-centre First In Human clinical investigation
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|
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. |
| 6 months following implantation |
| 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) | 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. | 30 days post procedure |
| hemoglobin assessment | Hemolysis screen measured by blood test | 6 months post procedure |
| Alanine transaminase (ALT) | Hemolysis screen measured by blood test of liver enzyme | 6 months post procedure |
| Aspartate transaminase (AST) | Hemolysis screen measured by blood test of liver enzyme | 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. | 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. | 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. | 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. | 6 months following implantation |
| Rate of hemorrhage | The rate will be compared to clinical outcomes for surgically implanted heart valves reported in the literature. | 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. | 6 months following implantation |
| Rate of Device deficiency | Device deficiency measured by echo | 6 months following implantation |
| D014694 |
| Ventricular Outflow Obstruction |