Surgical Bioprosthesis Aortic Valve Replacement Vs. Myval Balloon-Expandable THV Series in Patients Aged 65 to 75 With Symptomatic Severe Aortic Stenosis Judged Eligible by Heart Team
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Ceric Sàrl
- Enrollment
- 1,180
- Locations
- 49
- Primary Endpoint
- Primary safety endpoint at 1 month (non-inferiority): Composite measure of all-cause death, any stroke, bleeding, AKI stage 2-4, rehospitalization for a procedure-related event or or reintervention for aortic valve dysfunction.
Study Overview
Brief Summary
The study objective is to demonstrate that the clinical outcomes of the Myval balloon-expandable THV series are non-inferior to those of SAVR in patients with symptomatic severe aortic stenosis aged 65 to 75 years.
Detailed Description
Prospective, randomized, multinational, multicenter, open label, trial of 1180 patients treated with surgical bioprosthetic aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None (Participant)
Eligibility Criteria
- Ages
- 65 Years to 75 Years (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participant will be included if all the following criteria are met:
- •Patients aged ≥65 and ≤75
- •Symptomatic severe aortic stenosis (mean gradient≥40mmHg, and or peak velocity>4m/sec).
- •Patients with symptomatic heart disease due to severe native calcific aortic stenosis, as judged by a multidisciplinary heart team (including a cardiac surgeon), for whom SAVR or transfemoral TAVR is deemed feasible and approved by the local heart team.Signed informed consent for participation in the clinical investigation
Exclusion Criteria
- •Participant will not be included if any one of the following conditions exists:
- •Unable to understand and follow clinical investigation-related instructions or unable to comply with the clinical investigation protocol
- •Life expectancy less than 1 year
- •Known hypersensitivity or allergy to aspirin, clopidogrel or any Device frame components.
- •Under judicial protection, tutorship, or curatorship
- •Participation in another trial before the primary endpoint
Arms & Interventions
TAVR: Myval balloon-expandable THV Series
Myval balloon-expandable THV Series will be used for valve replacement
Intervention: Myval balloon-expandable THV Series (Device)
SAVR: Any surgical bioprosthetic valve commercially available at the clinical investigation site
Surgical bioprosthetic valve commercially available at the clinical investigation site will be used for valve replacement
Intervention: Surgical bioprosthetic valve (Device)
Outcomes
Primary Outcomes
Primary safety endpoint at 1 month (non-inferiority): Composite measure of all-cause death, any stroke, bleeding, AKI stage 2-4, rehospitalization for a procedure-related event or or reintervention for aortic valve dysfunction.
Time Frame: 1 month post procedure
Composite measure of all-cause death, any stroke, VARC-3 type 1 (only overt bleeding that requires a transfusion of 1 unit of whole blood/red blood cells (BARC 3a), type 2 and 3 bleeding, AKI stage 2-4, rehospitalization for a procedure-related event or reintervention for aortic valve dysfunction.
Primary efficacy endpoint at 1 year (non-inferiority): Composite measure of all-cause death, any stroke, or rehospitalization for valve related event
Time Frame: 1 year post procedure
Composite measure of all-cause death, any stroke, or rehospitalization for valve related event at 1 year (VARC-3 definition)
CT Scan Sub Study endpoints: primary endpoint : prevalence of feasible redoTAVR or ViV TAVR without requiring leaflet modifications techniques (green cases).
Time Frame: 1 month post procedure
Proportion of participants classified as "green cases" (redo-TAVR or ViV-TAVR feasible without leaflet modification) based on predefined CT scan criteria, including annular dimensions, coronary access, and valve frame interactions.
Secondary Outcomes
- Secondary Endpoint: Feasibility of re-TAVR based on CT scan evaluation (CT scan, for selected sites only)(1 month post procedure)
- Secondary Endpoint: Performance of the aortic valve : Gradients (mean/max) assessed by TTE(1 year and 3 years post procedure)
- Secondary Endpoint: Number of Participants Requiring New Permanent Pacemaker Implantation (PPI) Due to Conduction System Disturbances(1 month post procedure)
- Secondary Endpoint: Rate of prosthetic valve regurgitation (moderate or severe)(1 year post procedure)
- Secondary Endpoint: Number of Participants with Major Vascular Complications (VARC-3 Criteria)(1 month post procedure)
- Secondary Endpoint: Performance of the aortic valve : paravalvular leakage (PVL) grade evaluated by transthoracic echocardiogram (TTE)(1 year and 3 years post procedure)
- Secondary Endpoint: Performance of the aortic valve : effective orifice are (EOA) evaluated by transthoracic echocardiogram (TTE)(1 year and 3 years post procedure)
- CT Scan Sub Study endpoints: Secondary outcomes : feasibility of redoTAVR or ViV TAVR with or without requiring leaflet modification techniques(1 month post procedure)
- CT Scan Sub Study endpoints: Secondary outcomes: prevalence of HALT in both TAVR and SAVR groups(1 month post procedure)
- CT Scan Sub Study endpoints: Secondary outcomes: Impact of HALT on Mean Transvalvular Gradient - Valve Hemodynamics(1 month post procedure)
- CT Scan Sub Study endpoints: Secondary outcomes: Impact of HALT on Peak Transvalvular Gradient - Valve Hemodynamics(1 month post procedure)
- CT Scan Sub Study endpoints: Secondary outcomes: Impact of HALT on Effective Orifice Area (EOA) - Valve Hemodynamics(1 month post procedure)
- CT Scan Sub Study endpoints: Secondary outcomes: Mean Transvalvular Gradient - THV Hemodynamics(1 month post procedure)
- CT Scan Sub Study endpoints: Secondary outcomes: Peak Transvalvular Gradient - THV Hemodynamics(1 month post procedure)
- CT Scan Sub Study endpoints: Secondary outcomes: Effective Orifice Area (EOA) - THV Hemodynamics(1 month post procedure)
- CT Scan Sub Study endpoints: Secondary outcomes: Commissural Alignment of THV(1 month post procedure)
- Secondary Endpoint: Individual components of the primary endpoints: all cause mortality over time(1, 2, 3, 4, 5, 7, 9, and 10 years)
- Secondary Endpoint: Individual components of the primary endpoints: Stroke Over Time(1, 2, 3, 4, 5, 7, 9, and 10 years)
- Secondary Endpoint: Individual components of the primary endpoints: Bleeding Events (VARC-3 Type 1, 2, and 3) Over Time(1, 2, 3, 4, 5, 7, 9, and 10 years)
- Secondary Endpoint: Individual components of the primary endpoints: Acute Kidney Injury (AKI) Stage 2-4 Over Time(1, 2, 3, 4, 5, 7, 9, and 10 years)
- Secondary Endpoint: Individual components of the primary endpoints: Rehospitalization for Procedure-Related Event Over Time(1, 2, 3, 4, 5, 7, 9, and 10 years)
- Secondary Endpoint: Individual components of the primary endpoints: Reintervention for Aortic Valve Dysfunction Over Time(1, 2, 3, 4, 5, 7, 9, and 10 years)
- Secondary Endpoint: Number of Participants with Structural Valve Deterioration (VARC-3) and/or Requiring Redo-TAVR or Valve Explantation(5 years and 10 years post procedure)