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

Tracking Information

• First Submitted Date: June 28, 2017
• First Posted Date: December 26, 2017
• Last Update Posted Date: December 20, 2023
• Actual Study Start Date: August 8, 2017
• Actual Primary Completion Date: October 30, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 19, 2017)

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].

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 12, 2023)

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

Original Secondary Outcome Measures (submitted: December 19, 2017)

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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief 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
• 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
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

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

Condition

• Degenerative Aortic Valve Disease
• Aortic Stenosis
• Aortic Regurgitation

Intervention

• 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.
• 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.

Study Arms

• 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.
  Interventions:

  • Procedure: Edwards
  • Procedure: CoreValve
  • Procedure: Acurate neo
• 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).
  Intervention: Procedure: Standard

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: December 19, 2017): 300
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 30, 2024
• Actual Primary Completion Date: October 30, 2023 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 65 Years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT03383445
• Other Study ID Numbers: VIVA
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Josep Rodes-Cabau, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
• Original Responsible Party: Same as current
• Current Study Sponsor: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
• Verification Date: December 2023