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

NCT ID: NCT03383445

Last Updated: 2023-12-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-08
• Study Completion Date: 2024-05-30

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.

Conditions

Degenerative Aortic Valve Disease; Aortic Stenosis; Aortic Regurgitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Edwards

Intervention Type: PROCEDURE

The TAVR procedure will be performed with the Edwards SAPIEN XT or SAPIEN 3 valve (20, 23 or 26 mm).

CoreValve

Intervention Type: PROCEDURE

The TAVR procedure will be performed with the CoreValve Evolut R valve system (23 or 26 mm).

Acurate neo

Intervention Type: PROCEDURE

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).

Group Type: OTHER

Standard

Intervention Type: PROCEDURE

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.

Interventions

Edwards

The TAVR procedure will be performed with the Edwards SAPIEN XT or SAPIEN 3 valve (20, 23 or 26 mm).

Intervention Type: PROCEDURE

CoreValve

The TAVR procedure will be performed with the CoreValve Evolut R valve system (23 or 26 mm).

Intervention Type: PROCEDURE

Acurate neo

The TAVR procedure will be performed with the ACURATE neo aortic valve.

Intervention Type: 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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Josep Rodes-Cabau

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

IUCPQ

Québec, , Canada

Countries

Canada

References

Rodes-Cabau J, Ribeiro HB, Mohammadi S, Serra V, Al-Atassi T, Iniguez A, Vilalta V, Nombela-Franco L, Saez de Ibarra Sanchez JI, Auffret V, Forcillo J, Conradi L, Urena M, Moris C, Munoz-Garcia A, Paradis JM, Dumont E, Kalavrouziotis D, Maria Pomerantzeff P, Rosa VEE, Pezzute Lopes M, Sureda C, Diaz VAJ, Giuliani C, Avvedimento M, Pelletier-Beaumont E, Pibarot P; VIVA (Transcatheter Aortic Valve Replacement Versus Surgical Aortic Valve Replacement for Treating Elderly Patients With Severe Aortic Stenosis and Small Aortic Annuli) Trial Investigators. Transcatheter or Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis and Small Aortic Annulus: A Randomized Clinical Trial. Circulation. 2024 Feb 27;149(9):644-655. doi: 10.1161/CIRCULATIONAHA.123.067326. Epub 2023 Oct 26.

Reference Type: DERIVED

PMID: 37883682 (View on PubMed)

Other Identifiers

VIVA

Identifier Type: -

Identifier Source: org_study_id