aortic valve regurgitation heart valve disorder
Conditions
Interventions
Pre-procedural evaluation encompasses exclusion of obstructive coronary artery
disease by means of coronary angiography or non-invasive imaging techniques,
transthoracic echocardiography to assess f
Aorta Regurgitation
High risk for surgery individuals
Percutaneous trans-catheter repair
Sponsors
Inselspital and Bern University Hospital
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Age * 75 years - Patient with severe aortic stenosis defined by an aortic valve area (AVA) 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: 338-573mm2 AND perimeter range: 66-85mm) based on ECG-gated multislice computed tomographic measurements. Findings of 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. - Patient is able to give informed consent and provides consent in written or oral form in attendance of a witness - 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objective: to compare the performance of the Symetis ACURATE neo/TF to the Edwards SAPIEN 3 transcatheter aortic bioprosthesis with regard to early safety and clinical efficacy at 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives: to compare the Symetis ACURATE neo/TF with the Edwards SAPIEN 3 aortic bioprosthesis with regard to secondary clinical and echocardiographic endpoints at 30 days, 1 year and 3 years | — |
Countries
The Netherlands
Outcome results
None listed