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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Aortic Stenosis; Aortic Regurgitation; Degenerative Aortic Valve Disease
• Intervention / Treatment: Procedure: CoreValve; Procedure: Standard; Procedure: Edwards; Procedure: Acurate neo

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
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Josep Rodes-Cabau, MD; Phone Number: 418-656-8711; Email: josep.rodes@criucpq.ulaval.ca
• Study Contact Backup: Name: Emilie Pelletier Beaumont, MSc; Phone Number: 3929 418-656-8711; Email: emilie.pelletier-beaumont@criucpq.ulaval.ca

Study Locations

• Canada
  • Quebec, Canada, G1V 4G5
    • IUCPQ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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: CoreValve; The TAVR procedure will be performed with the CoreValve Evolut R valve system (23 or 26 mm).; Procedure: Edwards; The TAVR procedure will be performed with the Edwards SAPIEN XT or SAPIEN 3 valve (20, 23 or 26 mm).; Procedure: Acurate neo; The TAVR procedure will be performed with the ACURATE neo aortic valve.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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].	60 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2017
• Primary Completion (Actual): October 30, 2023
• Study Completion (Estimated): May 30, 2024

Study Registration Dates

• First Submitted: June 28, 2017
• First Submitted That Met QC Criteria: December 19, 2017
• First Posted (Actual): December 26, 2017

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Aortic Valve Insufficiency; Constriction, Pathologic; Aortic Valve Disease
• Other Study ID Numbers: VIVA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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