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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

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ClinicalTrials.gov Identifier: NCT03383445
Recruitment Status : Recruiting
First Posted : December 26, 2017
Last Update Posted : December 26, 2017
Sponsor:
Information provided by (Responsible Party):
Josep Rodes-Cabau, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

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: 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 ˂22mm, 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 Edwards SAPIEN 3 valve (20 or 23mm) 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  (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 : May 30, 2017
Estimated Primary Completion Date : May 30, 2018
Estimated Study Completion Date : May 30, 2024

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 0r 23 mm).
Procedure: CoreValve
The TAVR procedure will be performed with the CoreValve Evolut R valve system (23 or 26 mm).
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.



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, 1 year and 5 years ]
    Questionnaire, visual scale

  14. Exercise capacity [ Time Frame: 30 days, 1 year and 5 years ]
    Exercise capacity as evaluated by the six-minute walk test



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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
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 ˂22 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
  • Severe pulmonary disease
  • Dialysis-dependency
  • 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) 42
  • Non-calcific aortic stenosis
  • Severe mitral regurgitation
  • Moderate-to-severe tricuspid regurgitation requiring surgical repair

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03383445


Contacts
Contact: Josep Rodés-Cabau, MD 418-656-8711 josep.rodes@criucpq.ulaval.ca
Contact: Emilie Pelletier Beaumont, MSc 418-656-8711 ext 3929 emilie.pelletier-beaumont@criucpq.ulaval.ca

Locations
Canada
IUCPQ Recruiting
Quebec, Canada, G1V 4G5
Contact: Josep Rodes-Cabau, MD    418-656-8711    josep.rodes@criucpq.ulaval.ca   
Contact: Emilie Pelletier Beaumont, MSc    418-656-8711    emilie.pelletier-beaumont@criucpq.ulaval.ca   
Principal Investigator: Josep Rodes-Cabau, MD         
Sponsors and Collaborators
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Responsible Party: Josep Rodes-Cabau, MD, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
ClinicalTrials.gov Identifier: NCT03383445     History of Changes
Other Study ID Numbers: VIVA
First Posted: December 26, 2017    Key Record Dates
Last Update Posted: December 26, 2017
Last Verified: December 2017
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:
Constriction, Pathologic
Aortic Valve Stenosis
Aortic Valve Insufficiency
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction