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
- Conditions
- Degenerative Aortic Valve DiseaseAortic RegurgitationAortic Stenosis
- Interventions
- Procedure: EdwardsProcedure: StandardProcedure: CoreValveProcedure: Acurate neo
- Registration Number
- NCT03383445
- Lead Sponsor
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
- 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 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.
- 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 3D-CT or 3D-TEE). Patients will be randomized in a 1:1 fashion to either TAVR or SAVR. The TAVR procedure will be performed with the ACURATE neo Aortic Valve, the Edwards SAPIEN 3 valve (20, 23 or 26mm) or the CoreValve Evolut R or Evolut PRO valve system (23 or 26 mm).New iterations of these valve models may also be included. The SAVR procedure will be performed using standard techniques, with no limitation in terms of type and size of the valve prosthesis or surgical procedure (e.g. enlargement of the aortic root). For both TAVR and SAVR, the choice of the type and size of valve, access route (for TAVR), utilization of additional procedures such as root enlargement will be left at the discretion of heart team of the site treating the patient.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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).
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TAVR CoreValve The TAVR procedure will be performed following the standards of each participating center. No restriction or specific recommendation will be given regarding the approach, general vs. local abesthesia, Imaging guidance during the TAVR procedure, and post-procedural TAVR management. TAVR Edwards The TAVR procedure will be performed following the standards of each participating center. No restriction or specific recommendation will be given regarding the approach, general vs. local abesthesia, Imaging guidance during the TAVR procedure, and post-procedural TAVR management. TAVR Acurate neo The TAVR procedure will be performed following the standards of each participating center. No restriction or specific recommendation will be given regarding the approach, general vs. local abesthesia, Imaging guidance during the TAVR procedure, and post-procedural TAVR management. SAVR Standard SAVR procedure will be performed using standard techniques, with no limitation in terms of type and size of the valve prosthesis or surgical procedure (e.g. enlargement of the aortic root).
- Primary Outcome Measures
Name Time Method 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 \[Valve Academic Research Consortium-2 (VARC-2) definition\].
- Secondary Outcome Measures
Name Time Method Rate of AR 60 days, 1 year and 5 years Rate of moderate or severe AR
Mortality 30 days, 1 year and 5 years Death
Cardiac re-hospitalization 30 days, 1 year and 5 years Need for cardiac re-hospitalization
Combined Safety endpoint 30 days, 1 year and 5 years Death, stroke, major/life threatening bleeding
Quality of life 30 days, 60 days, 1 year and 5 years Questionnaire, visual scale
Stroke 30 days, 1 year and 5 years Stroke (Valve Academic Research Consortium-2 (VARC-2) definition)
Exercise capacity 60 days, 1 year and 5 years Exercise capacity as evaluated by the six-minute walk test
Rate of PPM 60 days, 1 year and 5 years Rate of moderate or severe PPM
Transvalvular gradient 60 days, 1 year and 5 years Mean transvalvular gradient
Bleeding 30 days, 1 year and 5 years Major or life threatening bleeding
Rate of new atrial fibrillation 30 days, 1 year and 5 years Rate of new-onset atrial fibrillation
Day of hospital stay For the duration of hospital stay Length of the hospitalization for the TAVR or SAVR procedure
Combined endpoints: rate of AR or PPM 1 year and 5 years Moderate or severe AR or severe PPM
Combined endpoints: LVEF and LV 60 days, 1 year and 5 years Changes in LVEF and LV hypertrophy
Trial Locations
- Locations (1)
IUCPQ
🇨🇦Quebec, Canada