Safety and Efficacy of the Symetis ACURATE Neo/TF Compared to the Edwards SAPIEN 3 Bioprosthesis.

Launched by INSEL GRUPPE AG, UNIVERSITY HOSPITAL BERN · Jan 2, 2017

Keywords

ClinConnect Summary

Background:

Transcatheter aortic valve implantation (TAVI) is an established and valuable treatment option for patients with severe symptomatic aortic stenosis and at increased risk for surgical aortic valve replacement (SAVR). The use of TAVI is rapidly expanding worldwide and the indications for TAVI are widening into lower risk populations in view of favorable outcomes among high and intermediate risk patients. Many novel devices are currently developed or established devices undergo design reiterations to address limitations, such as vascular access complications, paravalvular regurgit...

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Eligibility criteria

• Inclusion Criteria:
• • 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 increased risk for mortality if undergoing conventional surgical aortic valve replacement or judged as not operable as determined either
• • by a Logistic EuroSCORE \> 20 % OR
• • by a STS-PROM score \> 10% OR
• • by the heart team consisting of at least one cardiologist and cardiac surgeon based on the integration of individual clinical and anatomical factors not captured by risk-scores, the patient's age, frailty and life-expectancy
• • The heart team agrees on eligibility of the patient for participation and that TAVI by transfemoral access constitutes the most appropriate treatment modality, from which the patient will likely benefit most
• • Aortic annulus dimensions suitable for both valve types (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:
• • 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 with or without obstruction
• • 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