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

Aortic Stenosis Clinical 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03383445
• Other study ID #: VIVA
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 8, 2017
• Est. completion date: May 30, 2024

Study information

• Verified date: December 2023
• Source: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: May 30, 2024
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Regurgitation
• Aortic Stenosis
• Aortic Valve Disease
• Aortic Valve Insufficiency
• Aortic Valve Stenosis
• Constriction, Pathologic
• Degenerative Aortic Valve Disease

Intervention

Procedure:
• Edwards
The TAVR procedure will be performed with the Edwards SAPIEN XT or SAPIEN 3 valve (20, 23 or 26 mm).
• CoreValve
The TAVR procedure will be performed with the CoreValve Evolut R valve system (23 or 26 mm).
• Acurate neo
The TAVR procedure will be performed with the ACURATE neo aortic valve.
• Standard
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.

Locations

Country	Name	City	State
Canada	IUCPQ	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Country where clinical trial is conducted

Canada, 

Outcome

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