Clinical trial NCT06861361: Surgical Vs Transcatheter Aortic Valve Replacement in Young Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Symptomatic Severe Aortic Stenosis
Lead sponsor: Ceric Sàrl
Sponsor class: INDUSTRY
First posted: 2025-03-06
Enrollment: 1180
Sex: ALL
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria:

Participant will be included if all the following criteria are met:

1. Patients aged ≥65 and ≤75
2. Symptomatic severe aortic stenosis (mean gradient≥40mmHg, and or peak velocity\>4m/sec).
3. 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:

1. Unable to understand and follow clinical investigation-related instructions or unable to comply with the clinical investigation protocol
2. Life expectancy less than 1 year
3. Known hypersensitivity or allergy to aspirin, clopidogrel or any Device frame components.
4. Under judicial protection, tutorship, or curatorship
5. Participation in another trial before the primary endpoint

Primary outcomes:
measure: 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.
timeFrame: 1 month post procedure
measure: Primary efficacy endpoint at 1 year (non-inferiority): Composite measure of all-cause death, any stroke, or rehospitalization for valve related event
timeFrame: 1 year post procedure
measure: CT Scan Sub Study endpoints: primary endpoint : prevalence of feasible redoTAVR or ViV TAVR without requiring leaflet modifications techniques (green cases).
timeFrame: 1 month post procedure
Secondary outcomes:
measure: Secondary Endpoint: Individual components of the primary endpoints: all cause mortality over time
timeFrame: 1, 2, 3 and 5 years
measure: Secondary Endpoint: Individual components of the primary endpoints: Stroke Over Time
timeFrame: 1, 2, 3 and 5 years
measure: Secondary Endpoint: Individual components of the primary endpoints: Bleeding Events (VARC-3 Type 1, 2, and 3) Over Time
timeFrame: 1, 2, 3 and 5 years
measure: Secondary Endpoint: Individual components of the primary endpoints: Acute Kidney Injury (AKI) Stage 2-4 Over Time
timeFrame: 1, 2, 3 and 5 years
measure: Secondary Endpoint: Individual components of the primary endpoints: Rehospitalization for Procedure-Related Event Over Time
timeFrame: 1, 2, 3 and 5 years
measure: Secondary Endpoint: Individual components of the primary endpoints: Reintervention for Aortic Valve Dysfunction Over Time
timeFrame: 1, 2, 3 and 5 years
measure: Secondary Endpoint: Feasibility of re-TAVR based on CT scan evaluation (CT scan, for selected sites only)
timeFrame: 1 month post procedure
measure: Secondary Endpoint: Number of Participants Requiring New Permanent Pacemaker Implantation (PPI) Due to Conduction System Disturbances
timeFrame: 1 month post procedure
measure: Secondary Endpoint: Rate of prosthetic valve regurgitation (moderate or severe)
timeFrame: 1 year post procedure
measure: Secondary Endpoint: Number of Participants with Major Vascular Complications (VARC-3 Criteria)
timeFrame: 1 month post procedure
measure: Secondary Endpoint: Performance of the aortic valve : Gradients (mean/max) assessed by TTE
timeFrame: 1 year and 3 years post procedure
measure: Secondary Endpoint: Performance of the aortic valve : paravalvular leakage (PVL) grade evaluated by transthoracic echocardiogram (TTE)
timeFrame: 1 year and 3 years post procedure
measure: Secondary Endpoint: Performance of the aortic valve : effective orifice are (EOA) evaluated by transthoracic echocardiogram (TTE)
timeFrame: 1 year and 3 years post procedure
measure: Secondary Endpoint: Number of Participants with Structural Valve Deterioration (VARC-3) and/or Requiring Redo-TAVR or Valve Explantation
timeFrame: 5 years post procedure
measure: CT Scan Sub Study endpoints: Secondary outcomes : feasibility of redoTAVR or ViV TAVR with or without requiring leaflet modification techniques
timeFrame: 1 month post procedure
measure: CT Scan Sub Study endpoints: Secondary outcomes: prevalence of HALT in both TAVR and SAVR groups
timeFrame: 1 month post procedure
measure: CT Scan Sub Study endpoints: Secondary outcomes: Impact of HALT on Mean Transvalvular Gradient - Valve Hemodynamics
timeFrame: 1 month post procedure
measure: CT Scan Sub Study endpoints: Secondary outcomes: Impact of HALT on Peak Transvalvular Gradient - Valve Hemodynamics
timeFrame: 1 month post procedure
measure: CT Scan Sub Study endpoints: Secondary outcomes: Impact of HALT on Effective Orifice Area (EOA) - Valve Hemodynamics
timeFrame: 1 month post procedure
measure: CT Scan Sub Study endpoints: Secondary outcomes: Mean Transvalvular Gradient - THV Hemodynamics
timeFrame: 1 month post procedure
measure: CT Scan Sub Study endpoints: Secondary outcomes: Peak Transvalvular Gradient - THV Hemodynamics
timeFrame: 1 month post procedure
measure: CT Scan Sub Study endpoints: Secondary outcomes: Effective Orifice Area (EOA) - THV Hemodynamics
timeFrame: 1 month post procedure
measure: CT Scan Sub Study endpoints: Secondary outcomes: Commissural Alignment of THV
timeFrame: 1 month post procedure
Other outcomes:
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