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
300
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