The Use of ACURATE Neo 2 Valve in Patients With Symptomatic Aortic Valve Stenosis

Study Overview
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Brief Summary
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The objective of this study is to evaluate the ACURATE Neo2 in the Middle East population with severe, symptomatic aortic stenosis.

Detailed Description
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The MENA-TAVI study is an investigator-initiated, prospective, single-arm observational trial. Patients referred for or presenting with severe aortic stenosis requiring an intervention constitute the source population. The Heart Team consisting of interventional cardiologists and cardiovascular surgeons will evaluate the patients by integrating the available clinical data, the predicted 30-day mortality, individual factors affecting mortality such as frailty as well as the estimated life-expectancy and the patient's wishes to finally reach a consensus on the optimal treatment strategy with regards to transcatheter or surgical aortic valve replacement. Patients planned for TAVI will be screened for eligibility. If patients fulfill all inclusion and do not meet exclusion criteria, they will be informed about the study's purpose and course and will be asked for participation and written informed consent. In case of consent, they will be treated by the ACURATE neo2 aortic bioprosthesis. At discharge and at 30 days, the clinical outcomes composing the primary safety endpoint will be captured. Additional clinical, procedural and echocardiographic data will be obtained at discharge and at 30 days for assessment of secondary endpoints.

Official Title
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The Use of ACURATE Neo 2 Valve in Patients With Symptomatic Aortic Valve Stenosis

Conditions
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Severe Aortic Valve Stenosis

Intervention / Treatment
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* Device: Aortic valve replacement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject will be included if all of the following criteria are met: Patient with severe aortic stenosis defined by an aortic valve area (AVA) < 1cm2 or AVA indexed to body surface area (BSA) of < 0.6 cm2/m2, including low-flow severe aortic stenosis defined by stroke volume index (SVI) < 35ml/m2, as assessed by integration of echocardiographic and invasive measurements Subject is symptomatic (heart failure symptoms with New York Heart Association (NYHA) Functional Class > I, angina or syncope) Patient is considered at high (STS-PROM (Society of Thoracic Surgeons-Predicted Risk of Mortality) score >8) or intermediate (STS-PROM score >4) risk by the Heart Team. The heart team agrees on eligibility of the patient for participation and that TAVR (Transcatheter aortic valve replacement) (TAVR) by transfemoral access constitutes the most appropriate treatment modality, from which the patient will likely benefit most Aortic annulus dimensions suitable (area range: 338-573 mm2 AND perimeter range: 66-85 mm) based on ECG-gated multislice computed tomographic measurements. Findings of transesophageal echocardiography (TEE) and conventional aortography should be integrated in the anatomic assessment if available Arterial aorto-iliac-femoral axis suitable for transfemoral access with a minimum access vessel diameter ≥ 6 mm as assessed by multislice computed tomographic angiography and/or conventional angiography Written informed consent of the patient or her/his legal representative Patient understands the purpose, the potential risks as well as benefits of the trial and is willing to participate in all parts of the follow-up Exclusion Criteria: Subject will not be included if any one of the following conditions exists: Non-valvular aortic stenosis Congenital aortic stenosis or unicuspid or bicuspid aortic valve Non-calcific acquired aortic stenosis Anatomy not appropriate for transfemoral transcatheter aortic valve implantation due to size of the aortic annulus or degree or eccentricity of calcification of the native aortic valve or tortuosity of the aorta or ilio-femoral arteries Emergency procedure including patients in cardiogenic shock (low cardiac output, vasopressor dependence, mechanical hemodynamic support) Severely reduced left ventricular (LV) function (ejection fraction < 20%) Pre-existing prosthetic heart valve in aortic position Presence of mitral valve prosthesis Concomitant planned procedure except for percutaneous coronary intervention (PCI) Planned non-cardiac surgery within 30 days Stroke within 30 days of the procedure. Myocardial infarction within 30 days of the procedure (except type 2) Evidence of intra-cardiac mass, thrombus or vegetation Severe coagulation conditions Inability to tolerate anticoagulation/anti-platelet therapy Active bacterial endocarditis or other active infections Hypertrophic cardiomyopathy Contraindication to contrast media or allergy to nitinol Participation in another trial, which would lead to deviations in the preparation or performance of the intervention or the post-implantation management from this protocol
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Aortic valve replacement|Trans Aortic Valve Replacement (TAVI)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality | All deaths reported | Post-procedure discharge of patient from the hospital (Preferably 1- 3 days post procedure) | 
| Any stroke (disabling and non-disabling) | All stroke events | Post-procedure discharge of patient from the hospital (Preferably 1- 3 days post procedure) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success as defined by VARC-3 | Combined endpoint composed of: 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 to a major vascular or access-related, or cardiac structural complication | Post-procedure discharge of patient from the hospital (Preferably 1- 3 days post procedure) | 
| Device success as defined by VARC-3 | Combined endpoint composed of: Technical success Freedom from mortality Freedom from surgery or intervention related to the device or to a major vascular or access related or cardiac structural complication Intended performance of the valve (mean gradient <20mmHg, peak velocity <3 m/s, Doppler velocity index ≥0.25, and less than moderate aortic regurgitation) | Post-procedure discharge of patient from the hospital and at 30 days follow up | 
| Early safety as defined by VARC-3 | Combined endpoint composed of: Freedom from all-cause mortality Freedom from all stroke Freedom from VARC 3 type 2-4 bleeding Freedom from major vascular, access-related, or cardiac structural complication Freedom from acute kidney injury stage 3 or 4 Freedom from moderate or severe aortic regurgitation Freedom from new permanent pacemaker due to procedure related conduction abnormalities Freedom from surgery or intervention related to the device | At 30 days | 
| Modified combined early safety and clinical efficacy at 30 days as defined by the Valve Academic research Consortium (VARC-2) | All cause death) All stroke (disabling and non-disabling) Acute kidney injury (Stage 1 or 2, including renal replacement therapy) Coronary artery obstruction requiring intervention Major vascular complication Valve related dysfunction requiring repeat procedure Re-hospitalization for valve related symptoms or worsening congestive heart failure Valve related dysfunction Prosthetic aorta valve stenosis: mean aortic valve gradient >= 20 mmHg, effective orifice area (EOL) <= 1.1 cm2 (if body surface area >=1.6 m2) or <= 0.9 cm2 if BSA <1.6 m2 and/or Doppler velocity index <0.35 Moderate or severe prosthetic valve regurgitation according to VARC-2 | At 30 days | 
| Clinical efficacy as defined by VARC-3 | Combined endpoint composed of: Freedom from all-cause mortality Freedom from all stroke Freedom from hospitalization for procedure- or valve-related causes Combined endpoint composed of: Freedom from all-cause mortality Freedom from all stroke Freedom from hospitalization for procedure- or valve-related causes | At 30 days | 
| All-cause mortality | All deaths reported | At 30 days | 
| Valve-related mortality | All deaths related to valve | At 30 days | 
| All stroke (ischaemic, haemorrhagic) | All stroke reported | At 30 days | 
| Hospitalization (or re-hospitalization) | All hospitalization reported | At 30 days | 
| Bleeding and transfusions (VARC3 type 1 - 4) | All bleeding events reported | At 30 days | 
| Bioprosthetic valve dysfunction | (structural, non structural, thrombosis, endocarditis): (Stage 1 to 3) | At 30 days | 
| Clinically significant prosthetic valve thrombosis | Valve related thrombosis | At 30 days | 
| Implantation of permanent pacemaker | Pacemaker implantation | At 30 days | 
| Occurrence of atrial fibrilation | atrial fbrillation reported | At 30 days |