The optimal timing of surgical intervention in asymptomatic patients with severe aortic regurgitation remains controversial. As per cardiac magnetic resonance assessment, early surgical treatment will be compared with conventional guideline-based strategy in asymptomatic patients with severe aortic regurgitation.
Chronic asymptomatic aortic regurgitation grade 3 (moderate to severe) and grade 4 (severe)
No indication for the surgical treatment at the time of enrolment
LV ejection fraction >50%
Absence of more than mild-to-moderate concomitant valve disease or complex congenital heart disease
Age <18 years
Clearance Creatinine <30 mL/min
Contraindication for magnetic resonance (implanted active device, ferromagnetic implant incompatible with magnetic resonance scanner, cerebral aneurysm clip, metallic fragment in the eye or near sensitive tissue)
Pregnancy
Parallel
State of art aortic valve surgery
Procedure/SurgeryOptimal surgical treatment (aortic valve-sparing surgery, aortic valve replacement, Ross procedure).
Composite safety and efficacy endpoint at 12 months post-randomization (all 3 criteria must be fulfilled):
1. Reverse LV remodelling (CMR-derived EDVI decrease \>15% compared to baseline) 2. LV ejection fraction \>50% 3. Absence of MACE (cardiovascular mortality, stroke, myocardial infarction, heart failure, infective endocarditis)
Change in comparison to baseline:
1\) Quality of life questionnaire \>10%
Change in comparison to baseline:
2\) Spiroergometry - maximal oxygen consumption (VO2 max) \>10% and/or \>3 ml/kg/min
Normalization of N-terminal pro B-natriuretic peptide serum level
NT-proBNP \<112 ng/L
In hospital and 30 days mortality
Perioperative and/or early postoperative mortality
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Na Homolce Hospital
Lead sponsor
University Hospital Hradec Kralove
Collaborator
Centre of Cardiovascular and Transplantation Surgery, Czech Republic
Collaborator
St. Anne's University Hospital Brno, Czech Republic
Collaborator
VZW Cardiovascular Research Center Aalst
Collaborator
General University Hospital, Prague
Collaborator
University Clinical Centre of Republic of Srpska
Collaborator
AGEL Třinec-Podlesí Hospital
Collaborator
