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Degenerative Aortic Valve DiseaseNCT03383445

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

A study testing Edwards, CoreValve and Acurate neo in people with Degenerative Aortic Valve Disease and Aortic Stenosis, run by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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. Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
Edwards, CoreValve and Acurate neo
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteCanada
Study dates
8 Aug 2017to 30 May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • IUCPQ

    Québec, Quebec, G1V 4G5

Other trials in Canada

About this study

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.

Read the 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.

Being tested
Edwards, CoreValve, Acurate neo, Standard
Medical subject headings
Aortic Valve Stenosis, Aortic Valve Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EdwardsProcedure or surgery

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

  • CoreValveProcedure or surgery

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

  • Acurate neoProcedure or surgery

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

  • StandardProcedure or surgery

    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.

Study groups in NCT03383445
Study groupRoleWhat they receive
TAVROtherThe 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.
Receives: Procedure: Edwards; Procedure: CoreValve; Procedure: Acurate neo
SAVROtherSAVR 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).
Receives: Procedure: Standard

What is being measured

The primary outcome is the main question the study is designed to answer.

  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].

    Measured: 60 days

Secondary outcomes (14)

  1. Rate of PPM

    Rate of moderate or severe PPM

    Measured: 60 days, 1 year and 5 years

  2. Rate of AR

    Rate of moderate or severe AR

    Measured: 60 days, 1 year and 5 years

  3. Combined endpoints: rate of AR or PPM

    Moderate or severe AR or severe PPM

    Measured: 1 year and 5 years

  4. Transvalvular gradient

    Mean transvalvular gradient

    Measured: 60 days, 1 year and 5 years

  5. Combined endpoints: LVEF and LV

    Changes in LVEF and LV hypertrophy

    Measured: 60 days, 1 year and 5 years

  6. Mortality

    Death

    Measured: 30 days, 1 year and 5 years

  7. Stroke

    Stroke (Valve Academic Research Consortium-2 (VARC-2) definition)

    Measured: 30 days, 1 year and 5 years

  8. Bleeding

    Major or life threatening bleeding

    Measured: 30 days, 1 year and 5 years

  9. Rate of new atrial fibrillation

    Rate of new-onset atrial fibrillation

    Measured: 30 days, 1 year and 5 years

  10. Combined Safety endpoint

    Death, stroke, major/life threatening bleeding

    Measured: 30 days, 1 year and 5 years

  11. Cardiac re-hospitalization

    Need for cardiac re-hospitalization

    Measured: 30 days, 1 year and 5 years

  12. Day of hospital stay

    Length of the hospitalization for the TAVR or SAVR procedure

    Measured: For the duration of hospital stay

  13. Change if Quality of life

    Questionnaire, visual scale

    Measured: 30 days, 60 days, 1 year and 5 years

  14. Exercise capacity

    Exercise capacity as evaluated by the six-minute walk test

    Measured: 60 days, 1 year and 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Dec 2017
  2. Study start8 Aug 2017
  3. Primary completion30 Oct 2023
  4. Study completion30 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients will be randomized in a 1:1 fashion to either TAVR or SAVR
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03383445
Sponsor's protocol ID
VIVA
Status last verified
Mar 2026
First submitted
28 Jun 2017
Last updated
27 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37883682

Questions about this trial

What is this clinical trial studying?

A study testing Edwards, CoreValve and Acurate neo in people with Degenerative Aortic Valve Disease and Aortic Stenosis, run by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Valve performance: rate of prothesis-patient mismatch (PPM) and/or aortic regurgitation (AR) (time frame: 60 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03383445, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.

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