Transcatheter Aortic Valve Replacement Versu Surgical Aortix Valve Replacement for Treating Elderly Patients With Severe Aortic Stenosis and Small Aortic Annuli: A Prospective Randomized Study The VIVA Trial
Edwards: The TAVR procedure will be performed with the Edwards SAPIEN XT or SAPIEN 3 valve (20, 23 or 26 mm).
CoreValve: The TAVR procedure will be performed with the CoreValve Evolut R valve system (23 or 26 mm).
Acurate neo: The TAVR procedure will be performed with the ACURATE neo aortic valve.
Standard: The choice of the type and size of valve, utilization of additional procedures such as root enlargement will be left at the discretion of heart team of the treating the patient.
Study summary
To date, no formal, randomized, prospective, head-to-head comparisons of surgical aortic valve replacement (SAVR) versus transcatheter aortic valve replacement (TAVR) have been undertaken in the severe aortic stenosis (AS) population with small aortic annuli. Objectives of the present study are to compare the hemodynamic performance (incidence of severe PPM and ≥ moderate AR) and clinical outcomes (death, stroke, major or life threatening bleeding) between TAVR and SAVR in patients with severe AS and small aortic annuli.
Eligibility
Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Patients ≥65 years-old diagnosed with severe AS (defined as: jet velocity ≥ 4.0 m/s or mean gradient ≥ 40 mmHg or velocity ratio \<0.25 AND aortic valve area ≤ 1.0 cm2 or aortic valve area index ≤ 0.6 cm2/m2; OR mean gradient \>30 mmHg AND aortic valve area ≤ 1.0 cm2 or aortic valve area index ≤ 0.6 cm2/m2 AND \>1200 Agatston units for women or \>2000 Agatston units for men as determined by non-contrast CT).
* Small aortic annulus defined as a mean aortic annulus diameters ˂23 mm and a minimal aortic annulus diameter of ≤21.5 mm as measured by 3D-computed tomography (CT) and/or 3D-transesophageal echocardiography (TEE).
Exclusion Criteria:
* Prohibitive surgical risk as determined by the Heart Team
* Porcelain aorta
* Aortic root dilatation \>45 mm
* Coronary artery disease (CAD) not treatable by percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG), or SYNTAX score \>32 (in the absence of prior revascularization) or severe left main disease
* Non-calcific aortic stenosis
* Severe mitral regurgitation
* Moderate-to-severe tricuspid regurgitation requiring surgical repair
* Prior surgical valve in aortic position
Primary outcome measure(s)
Valve performance: rate of prothesis-patient mismatch (PPM) and/or aortic regurgitation (AR) — 60 days Severe PPM \[defined as an indexed aortic valve area ≤0.65 cm2/m2 \] and/or ≥moderate AR \[Valve Academic Research Consortium-2 (VARC-2) definition\].
Trial sites (1)
Facility
City
Region
Status
IUCPQ
Québec
Quebec
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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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