Status:
UNKNOWN
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
Lead Sponsor:
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Conditions:
Degenerative Aortic Valve Disease
Aortic Stenosis
Eligibility:
All Genders
65+ years
Phase:
NA
Brief 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 sever...
Detailed Description
This is a prospective, multicenter, randomized open-label trial including patients with severe AS and small aortic annulus (mean aortic annuli diameter ˂23mm and minimal diameter ≤21.5mm, evaluated by...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 8 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2024
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT03383445
Start Date
August 8 2017
End Date
May 30 2024
Last Update
December 20 2023
Active Locations (1)
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1
IUCPQ
Québec, Canada, G1V 4G5