Early Valve Replacement Guided by Biomarkers of LV Decompensation in Asymptomatic Patients With Severe AS (EVoLVeD)
Aortic Valve Stenosis, Hypertrophy, Left Ventricular
About this trial
This is an interventional treatment trial for Aortic Valve Stenosis
Eligibility Criteria
Inclusion Criteria:
- Severe aortic stenosis (aortic valve jet velocity ≥4.0 m/s, or aortic valve area indexed to body surface area <0.6cm2/m2 with aortic jet velocity ≥3.5m/s)
- Age over 18 years
- No symptoms attributable to aortic stenosis that require aortic valve replacement
Exclusion Criteria:
- Deemed lower risk for mid-wall fibrosis on screening
- Planned cardiac surgery
- Previous valve replacement
- Severe hypertension (systolic >180 or diastolic >110 mmHg)
- Acute pulmonary oedema or cardiogenic shock
- Left ventricular ejection fraction <50% on cardiac MRI
- Significant abnormalities on cardiac MRI that would prevent enrolment
- Coexistent severe aortic regurgitation or mitral regurgitation
- Coexistent mitral stenosis greater than mild in severity
- Coexistent hypertrophic cardiomyopathy or cardiac amyloidosis
- Any contraindication to MRI scanning (such as permanent pacemaker)
- Advanced renal impairment (glomerular filtration rate <30 mL/min/1.73 m2)
- Pregnancy or breast feeding
- Patient judged to be unfit to be considered for aortic valve replacement or transcatheter aortic valve implantation
- Patient declines to consider undergoing valve replacement surgery or transcatheter aortic valve implantation
- Inability to give informed consent
- Previous randomisation into this study
Sites / Locations
- NHS Lothian
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
No Intervention
No Intervention
No Intervention
Group A: Early intervention
Group B: Routine care
Group C: Routine care
Group D: No further study follow up
Patients will be referred immediately for aortic valve intervention.
Patients will be invited back for clinical follow up according to local policy. Decision making regarding future aortic valve intervention will be taken by the participant's clinical team (cardiologist and cardiac surgeon).
Patients will be invited back for clinical follow up according to local policy. Decision making regarding future aortic valve intervention will be taken by the patient's clinical team (cardiologist and cardiac surgeon). Group C will appear identical to Group B
Patients will be invited back for clinical follow up according to local policy. Decision making regarding future aortic valve intervention will be taken by the patient's clinical team (cardiologist and cardiac surgeon). No further study follow up will take place but personal data will be retained for future data linkage.