Randomized Trial of TAVI vs. SAVR in Patients With Severe Aortic Valve Stenosis at Low to Intermediate Risk of Mortality

Ki vehet részt

• Heart team consensus that TAVI and SAVR are both medically justified and advisable based on:; Degenerative aortic valve stenosis with echocardiographically derived criteria:; Mean gradient >40 mmHg or; Jet velocity greater than 4.0 m/s or; Aortic valve area (AVA) of < 1.0 cm2 (indexed effective orifice area < 0.6cm2/m2); Patient is symptomatic from his/her aortic valve stenosis; New York Heart Association Functional Class ≥ II or; Angina pectoris or; Syncope; Patient is classified as low to intermediate operative risk as assessed by the local heart team according to the variables outlined in the 2017 ESC/EACTS Guidelines for the Management of valvular heart disease, taking into account cardiac and extracardiac Patient characteristics and established risk scores (e.g. STS-PROM, EuroSCORE); A transfemoral or alternative (e.g. transapical, transaortic, transaxillary) access for TAVI seems feasible. Centers should follow a "transfemoral first" strategy for the primary route of access; however, other routes of access are also allowed, as decided by local heart team consensus
• Patient has provided written informed consent to participate in the trial
• Ability of the patient to understand the patient information and to personally sign and date the informed consent to participate in the study, before performing any study related procedures
• The patient agrees to undergo SAVR, if randomized to control treatment
• The patient and the treating physician agree that the patient will return for all required post-procedure follow-up visits
• Patients aged 65 to 85 years
• Male patients or females who are postmenopausal defined as no menses for 12 months without an alternative medical cause

Ki nem vehet részt

• Previous cardiac surgery
• Any percutaneous coronary intervention performed within 1 month prior to the study procedure
• Currently participating in another investigational drug or device trial
• Untreated clinically significant coronary artery disease considered a contraindication to an isolated aortic valve procedure (TAVI or SAVR) according to heart team consensus
• Ischemic stroke or intracranial bleeding within 1 month
• Any other condition considered a contraindication for an isolated aortic valve procedure
• Symptomatic carotid or vertebral artery disease
• Expected life expectancy < 12 months due to associated non-cardiac comorbidities
• Severe ventricular dysfunction with left ventricular ejection fraction < 20% as measured by resting echocardiogram
• Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified
• Untreated severe mitral or tricuspid regurgitation
• Untreated severe mitral stenosis
• Hemodynamic instability requiring inotropic support or mechanical circulatory support
• Hypertrophic obstructive cardiomyopathy or severe basal septal hypertrophy with outflow gradient
• Echocardiographic evidence of an intracardiac mass, thrombus, vegetation or endocarditis