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 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 ˂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

Primary Outcome

Valve performance: rate of prothesis-patient mismatch (PPM) and/or aortic regurgitation (AR)

Secondary Outcome

 Rate of PPM

Condition

Degenerative Aortic Valve Disease

Intervention

Edwards

Study Arms / Comparison Groups

 TAVR

Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

Start Date

May 30, 2017

Completion Date

May 30, 2024

Primary Completion Date

May 30, 2021

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 ˂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

Gender

All

Ages

65 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, 418-656-8711, [email protected]

Location Countries

Canada

Location Countries

Canada

Administrative Informations

NCT ID

NCT03383445

Organization ID

VIVA

Responsible Party

Principal Investigator

Study Sponsor

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

Study Sponsor

, ,

Verification Date

January 2020