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

• ClinicalTrials.gov Identifier: NCT03383445
• Recruitment Status: Active, not recruiting
• First Posted: December 26, 2017
• Last Update Posted: December 20, 2023
• Sponsor: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
• Information provided by (Responsible Party): Josep Rodes-Cabau, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

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.

Condition or disease	Intervention/treatment	Phase
Degenerative Aortic Valve Disease; Aortic Stenosis; Aortic Regurgitation	Procedure: Edwards; Procedure: CoreValve; Procedure: Acurate neo; Procedure: Standard	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Patients will be randomized in a 1:1 fashion to either TAVR or SAVR
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: August 8, 2017
• Actual Primary Completion Date: October 30, 2023
• Estimated Study Completion Date: May 30, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Valve performance: rate of prothesis-patient mismatch (PPM) and/or aortic regurgitation (AR) [ Time Frame: 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 :

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

Eligibility Criteria

• Ages Eligible for Study: 65 Years and older (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Canada

IUCPQ

Quebec, Canada, G1V 4G5

Sponsors and Collaborators

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

More Information

• Responsible Party: Josep Rodes-Cabau, MD, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
• ClinicalTrials.gov Identifier: NCT03383445
• Other Study ID Numbers: VIVA
• First Posted: December 26, 2017
• Last Update Posted: December 20, 2023
• Last Verified: December 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Aortic Valve Stenosis; Aortic Valve Disease; Aortic Valve Insufficiency; Constriction, Pathologic; Pathological Conditions, Anatomical; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction