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

NCT03383445 | Active Not Recruiting

• 1 other identifier: VIVA
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Degenerative Aortic Valve Disease; Aortic Stenosis; Aortic Regurgitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Rate of PPM

  60 days, 1 year and 5 years

• Rate of AR

  60 days, 1 year and 5 years

• Combined endpoints: rate of AR or PPM

  1 year and 5 years

• Transvalvular gradient

  60 days, 1 year and 5 years

• Combined endpoints: LVEF and LV

  60 days, 1 year and 5 years

Study Arms (2)

TAVR

OTHER

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

OTHER

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

Interventions

Edwards PROCEDURE

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

TAVR

CoreValve PROCEDURE

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

TAVR

Acurate neo PROCEDURE

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

TAVR

Standard 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.

SAVR

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec: lead

Study Sites (1)

IUCPQ

Québec, Quebec, G1V 4G5, Canada

Location

Related Publications (1)

• 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.

  PMID: 37883682 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis; Aortic Valve Insufficiency

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Patients will be randomized in a 1:1 fashion to either TAVR or SAVR

Study Record Dates

• First Submitted: June 28, 2017
• First Posted: December 26, 2017
• Study Start: August 8, 2017
• Primary Completion: October 30, 2023
• Study Completion (Estimated): May 30, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)