An interventional study of Edwards and CoreValve in Degenerative Aortic Valve Disease, Aortic Stenosis and Aortic Regurgitation, sponsored by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec. Active, not recruiting at 1 site in Canada. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec · Not applicable, Interventional, and Treatment
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.
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.
1,025 studies on the registry are indexed under Aortic Valve Stenosis; 293 are open to participants now.
This study's planned enrollment of 300 is above the median of 126 across 554 interventional studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec is the lead sponsor of 23 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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 · Procedure: CoreValve · Procedure: Acurate neo
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
The TAVR procedure will be performed with the Edwards SAPIEN XT or SAPIEN 3 valve (20, 23 or 26 mm).
The TAVR procedure will be performed with the CoreValve Evolut R valve system (23 or 26 mm).
The TAVR procedure will be performed with the ACURATE neo aortic valve.
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.
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 \[Valve Academic Research Consortium-2 (VARC-2) definition\].
Time frame: 60 days
Rate of PPM
Rate of moderate or severe PPM
Time frame: 60 days, 1 year and 5 years
Rate of AR
Rate of moderate or severe AR
Time frame: 60 days, 1 year and 5 years
Combined endpoints: rate of AR or PPM
Moderate or severe AR or severe PPM
Time frame: 1 year and 5 years
Transvalvular gradient
Mean transvalvular gradient
Time frame: 60 days, 1 year and 5 years
Combined endpoints: LVEF and LV
Changes in LVEF and LV hypertrophy
Time frame: 60 days, 1 year and 5 years
Mortality
Death
Time frame: 30 days, 1 year and 5 years
Stroke
Stroke (Valve Academic Research Consortium-2 (VARC-2) definition)
Time frame: 30 days, 1 year and 5 years
Bleeding
Major or life threatening bleeding
Time frame: 30 days, 1 year and 5 years
Rate of new atrial fibrillation
Rate of new-onset atrial fibrillation
Time frame: 30 days, 1 year and 5 years
Combined Safety endpoint
Death, stroke, major/life threatening bleeding
Time frame: 30 days, 1 year and 5 years
Cardiac re-hospitalization
Need for cardiac re-hospitalization
Time frame: 30 days, 1 year and 5 years
Day of hospital stay
Length of the hospitalization for the TAVR or SAVR procedure
Time frame: For the duration of hospital stay
Change if Quality of life
Questionnaire, visual scale
Time frame: 30 days, 60 days, 1 year and 5 years
Exercise capacity
Exercise capacity as evaluated by the six-minute walk test
Time frame: 60 days, 1 year and 5 years
Plan to share: No
Ran from Aug 2017 to primary completion in Oct 2023, 74 months.
Of 177 non-industry interventional studies with no phase under Aortic Valve Stenosis, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 79. This study's 74 months is above that.
Counting every sponsor, half of 288 studies reached it within 33 months; a quarter within 18 and three quarters within 72.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec