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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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
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Degenerative Aortic Valve Disease, Aortic Stenosis, Aortic Regurgitation

Intervention / Treatment
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* Procedure: Edwards
* Procedure: CoreValve
* Procedure: Acurate neo
* Procedure: Standard


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomized in a 1:1 fashion to either TAVR or SAVR
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: TAVR<br>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. | Procedure: Edwards<br>* The TAVR procedure will be performed with the Edwards SAPIEN XT or SAPIEN 3 valve (20, 23 or 26 mm).<br>Procedure: CoreValve<br>* The TAVR procedure will be performed with the CoreValve Evolut R valve system (23 or 26 mm).<br>Procedure: Acurate neo<br>* The TAVR procedure will be performed with the ACURATE neo aortic valve.<br>|
| Other: SAVR<br>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). | Procedure: Standard<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Valve performance: rate of prothesis-patient mismatch (PPM) and/or aortic regurgitation (AR) | 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]. | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of PPM | Rate of moderate or severe PPM | 60 days, 1 year and 5 years | 
| Rate of AR | Rate of moderate or severe AR | 60 days, 1 year and 5 years | 
| Combined endpoints: rate of AR or PPM | Moderate or severe AR or severe PPM | 1 year and 5 years | 
| Transvalvular gradient | Mean transvalvular gradient | 60 days, 1 year and 5 years | 
| Combined endpoints: LVEF and LV | Changes in LVEF and LV hypertrophy | 60 days, 1 year and 5 years | 
| Mortality | Death | 30 days, 1 year and 5 years | 
| Stroke | Stroke (Valve Academic Research Consortium-2 (VARC-2) definition) | 30 days, 1 year and 5 years | 
| Bleeding | Major or life threatening bleeding | 30 days, 1 year and 5 years | 
| Rate of new atrial fibrillation | Rate of new-onset atrial fibrillation | 30 days, 1 year and 5 years | 
| Combined Safety endpoint | Death, stroke, major/life threatening bleeding | 30 days, 1 year and 5 years | 
| Cardiac re-hospitalization | Need for cardiac re-hospitalization | 30 days, 1 year and 5 years | 
| Day of hospital stay | Length of the hospitalization for the TAVR or SAVR procedure | For the duration of hospital stay | 
| Quality of life | Questionnaire, visual scale | 30 days, 60 days, 1 year and 5 years | 
| Exercise capacity | Exercise capacity as evaluated by the six-minute walk test | 60 days, 1 year and 5 years |