Transcatheter aortic valve replacement: Retrograde transfemoral transcatheter aortic valve replacement with any CE mark approved aortic bioprosthesis with or without concomitant percutaneous coronary intervention.
Surgical aortic valve replacement: Conventional surgical aortic valve replacement with a bioprosthesis using normothermic cardiopulmonary bypass and cold blood cardioplegia cardiac arrest with or without concomitant coronary artery bypass graft surgery.
Study summary
A randomized clinical trial investigating transcatheter (TAVR) versus surgical (SAVR) aortic valve replacement in patients 75 years of age or younger suffering from severe aortic valve stenosis.
Study hypothesis: The clinical outcome (death of any cause, stroke and rehospitalization (related to the procedure, valve or heart failure)) obtained within one year after TAVR is non-inferior to SAVR.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* Age 75 years or younger.
* Severe calcific AS (Valve area \<1cm2 (or \<0.6 cm2/m2) AND one of the two following criteria: mean gradient \>40mmHg or peak jet velocity \>4.0m/s, OR in presence of low flow, low gradient with reduced or normal LVEF\<50%, a dobutamine stress echo should verify true severe AS rather than pseudo-AS
* Symptomatic with angina pectoris, dyspnea or exercise-induced syncope or near syncope OR asymptomatic with abnormal exercise test showing symptoms on exercise clearly related to AS or systolic LV dysfunction (LVEF \<50%) not due to another cause.
* Anticipated usage of biological aortic valve prosthesis.
* Low risk for conventional surgery (STS Score \<4%).
* Suitable for both SAVR and transfemoral TAVR.
* Life expectancy \>1 year after the intervention.
* Informed consent to participate in the study after adequate information about the study before randomization and intervention.
Exclusion Criteria:
* Coronary artery disease, not suitable for both percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG).
* Coronary angiogram with a SYNTAX-score \>22.
* LVEF \<25% without contractile reserve during dobutamine stress echocardiography.
* Porcelain aorta, which prevents open-heart surgery.
* Bicuspid valve with aorta ascendens diameter ≥45mm
* Severe femoral, iliac or aortic atherosclerosis, calcification, coarctation, aneurysm or tortuosity, which prevents transfemoral TAVR.
* Need for open heart surgery other than SAVR with or without CABG.
* Myocardial infarction within last 30 days
* Stroke or TIA within the last 30 days. NOTION-2, 01. February 2017, version 5 9
* Current endocarditis, intracardiac tumor, thrombus or vegetation.
* Ongoing severe infection requiring intravenous antibiotics.
* Unstable pre-procedural condition requiring intravenous inotropes or mechanical assist device (IABP, Impella) on the day of intervention.
* Kidney disease requiring dialysis or severely impaired lung function (FEV1 and/or diffusion capacity \<40% of predicted).
* Allergy to heparin, iodid contrast agent, warfarin, aspirin or clopidogrel.
Primary outcome measure(s)
Composite rate of all-cause mortality, stroke and rehospitalization (related to the procedure, the valve or heart failure) within one year after the procedure. — at one year post-procedural. VARC-3 definitions
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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