Back to resultsTranscatheter 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
Primary Purpose
Degenerative Aortic Valve Disease, Aortic Stenosis, Aortic Regurgitation
Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Edwards
CoreValve
Acurate neo
Standard
Sponsored by
About this trial
This is an interventional treatment trial for Degenerative Aortic Valve Disease
Eligibility Criteria
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 ˂22 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
- Severe pulmonary disease
- Dialysis-dependency
- 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) 42
- Non-calcific aortic stenosis
- Severe mitral regurgitation
- Moderate-to-severe tricuspid regurgitation requiring surgical repair
Sites / Locations
- IUCPQ
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
TAVR
SAVR
Arm Description
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 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).
Outcomes
Primary Outcome Measures
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].
Secondary Outcome Measures
Rate of PPM
Rate of moderate or severe PPM
Rate of AR
Rate of moderate or severe AR
Combined endpoints: rate of AR or PPM
Moderate or severe AR or severe PPM
Transvalvular gradient
Mean transvalvular gradient
Combined endpoints: LVEF and LV
Changes in LVEF and LV hypertrophy
Mortality
Death
Stroke
Stroke (Valve Academic Research Consortium-2 (VARC-2) definition)
Bleeding
Major or life threatening bleeding
Rate of new atrial fibrillation
Rate of new-onset atrial fibrillation
Combined Safety endpoint
Death, stroke, major/life threatening bleeding
Cardiac re-hospitalization
Need for cardiac re-hospitalization
Day of hospital stay
Length of the hospitalization for the TAVR or SAVR procedure
Quality of life
Questionnaire, visual scale
Exercise capacity
Exercise capacity as evaluated by the six-minute walk test
Full Information
NCT ID
NCT03383445
First Posted
June 28, 2017
Last Updated
September 12, 2023
Sponsor
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
1. Study Identification
Unique Protocol Identification Number
NCT03383445
Brief Title
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
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 8, 2017 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
May 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Aortic Valve Disease, Aortic Stenosis, Aortic Regurgitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized in a 1:1 fashion to either TAVR or SAVR
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TAVR
Arm Type
Other
Arm Description
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.
Arm Title
SAVR
Arm Type
Other
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
Edwards
Intervention Description
The TAVR procedure will be performed with the Edwards SAPIEN XT or SAPIEN 3 valve (20, 23 or 26 mm).
Intervention Type
Procedure
Intervention Name(s)
CoreValve
Intervention Description
The TAVR procedure will be performed with the CoreValve Evolut R valve system (23 or 26 mm).
Intervention Type
Procedure
Intervention Name(s)
Acurate neo
Intervention Description
The TAVR procedure will be performed with the ACURATE neo aortic valve.
Intervention Type
Procedure
Intervention Name(s)
Standard
Intervention Description
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.
Primary Outcome Measure Information:
Title
Valve performance: rate of prothesis-patient mismatch (PPM) and/or aortic regurgitation (AR)
Description
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].
Time Frame
60 days
Secondary Outcome Measure Information:
Title
Rate of PPM
Description
Rate of moderate or severe PPM
Time Frame
60 days, 1 year and 5 years
Title
Rate of AR
Description
Rate of moderate or severe AR
Time Frame
60 days, 1 year and 5 years
Title
Combined endpoints: rate of AR or PPM
Description
Moderate or severe AR or severe PPM
Time Frame
1 year and 5 years
Title
Transvalvular gradient
Description
Mean transvalvular gradient
Time Frame
60 days, 1 year and 5 years
Title
Combined endpoints: LVEF and LV
Description
Changes in LVEF and LV hypertrophy
Time Frame
60 days, 1 year and 5 years
Title
Mortality
Description
Death
Time Frame
30 days, 1 year and 5 years
Title
Stroke
Description
Stroke (Valve Academic Research Consortium-2 (VARC-2) definition)
Time Frame
30 days, 1 year and 5 years
Title
Bleeding
Description
Major or life threatening bleeding
Time Frame
30 days, 1 year and 5 years
Title
Rate of new atrial fibrillation
Description
Rate of new-onset atrial fibrillation
Time Frame
30 days, 1 year and 5 years
Title
Combined Safety endpoint
Description
Death, stroke, major/life threatening bleeding
Time Frame
30 days, 1 year and 5 years
Title
Cardiac re-hospitalization
Description
Need for cardiac re-hospitalization
Time Frame
30 days, 1 year and 5 years
Title
Day of hospital stay
Description
Length of the hospitalization for the TAVR or SAVR procedure
Time Frame
For the duration of hospital stay
Title
Quality of life
Description
Questionnaire, visual scale
Time Frame
30 days, 60 days, 1 year and 5 years
Title
Exercise capacity
Description
Exercise capacity as evaluated by the six-minute walk test
Time Frame
60 days, 1 year and 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
IUCPQ
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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
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