An interventional study of Myval balloon-expandable THV Series and Surgical bioprosthetic valve in Symptomatic Severe Aortic Stenosis, sponsored by Ceric Sàrl. Recruiting at 49 sites in 14 countries. Open to participants aged 65 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-12.
Sponsored by Ceric Sàrl · Not applicable, Interventional, and Treatment
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.
Prospective, randomized, multinational, multicenter, open label, trial of 1180 patients treated with surgical bioprosthetic aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR).
1,025 studies on the registry are indexed under Aortic Valve Stenosis; 293 are open to participants now.
This study's planned enrollment of 1,180 is above the median of 126 across 554 interventional studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →Ceric Sàrl is the lead sponsor of 17 studies on the registry; 11 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participant will be included if all the following criteria are met:
Exclusion Criteria:
Participant will not be included if any one of the following conditions exists:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Myval balloon-expandable THV Series will be used for valve replacement
Device: Myval balloon-expandable THV Series
Surgical bioprosthetic valve commercially available at the clinical investigation site will be used for valve replacement
Device: Surgical bioprosthetic valve
Patients receive Myval balloon-expandable THV Series (TAVR)
Patients receive any surgical bioprosthetic valve commercially available at the clinical investigation site (SAVR)
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.
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.
Time frame: 1 month post procedure
Primary efficacy endpoint at 1 year (non-inferiority): Composite measure of all-cause death, any stroke, or rehospitalization for valve related event
Composite measure of all-cause death, any stroke, or rehospitalization for valve related event at 1 year (VARC-3 definition)
Time frame: 1 year post procedure
CT Scan Sub Study endpoints: primary endpoint : prevalence of feasible redoTAVR or ViV TAVR without requiring leaflet modifications techniques (green cases).
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.
Time frame: 1 month post procedure
Secondary Endpoint: Individual components of the primary endpoints: all cause mortality over time
Number of participants who experience all-cause mortality at each follow-up time point.
Time frame: 1, 2, 3, 4, 5, 7, 9, and 10 years
Secondary Endpoint: Individual components of the primary endpoints: Stroke Over Time
Number of participants with any stroke (ischemic or hemorrhagic) as defined by clinical assessment and imaging confirmation.
Time frame: 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
Number of participants experiencing bleeding events classified as VARC-3 type 1 (BARC 3a), type 2 and 3. * Scoring System: Valve Academic Research Consortium (VARC) scale: * 1 * Overt bleeding not requiringing surgical or percutaneous intervention, but requiring medical intervention, leading to hospitalization, an increased level of care, or medical evaluation * Overt bleeding requiring a transfusion of 1 unit of whole blood/RBC * 3 * Overt bleeding in a critical organ, such as intracranial, intraspinal, intraocular, pericardial or intramuscular with compartment syndrome * Overt bleeding causing hypovolemic shock or severe hypotension * Overt bleeding requiring reoperation, surgical exploration, or re-intervention for the purpose of controlling bleeding * Post-thoracotomy chest tube output ≥2 L within 24-h * Overt bleeding requiring a transfusion of ≥5 units of whole blood/RBC * Overt bleeding associated with a haemoglobin drop ≥5 g/dL * Higher scores indicate worst outcomes
Time frame: 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
Number of participants with acute kidney injury (AKI) stage 2-4 based on VARC-3 * Scale Information: AKI from Valve Academic Research Consortium 3 (VARC-3): * Scoring System: * Stage 1: AKI that fulfils at least one of the following criteria: * Increase in serum creatinine ≥150-200% (≥1.5-2.0x increase) within 7 days compared with baseline * Increase of ≥ 0.3mg/dL (≥26.4 μmol/L) within 48 h of the index procedure o Stage 2: AKI that fulfils the following criterion: * Increase in serum creatinine \>200-300% (\>2.0-3.0x increase) within 7 days compared with baseline o Stage 3: AKI that fulfils at least one of the following criteria: * Increase in serum creatinine \>300% (\>3.0x increase) within 7 days compared with baseline * Serum creatinine ≥4.0 mg/dL (≥354 μmol/L) with an acute increase of ≥0.5 mg/dL (≥44 μmol/L) * Stage 4: AKI requiring new temporary or permanent renal replacement therapy * Interpretation: Higher stages indicate more severe kidney injury
Time frame: 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
Number of participants requiring rehospitalization due to procedure-related complications.
Time frame: 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
Number of participants requiring reintervention (redo-TAVR, SAVR, or valve explantation) due to aortic valve dysfunction.
Time frame: 1, 2, 3, 4, 5, 7, 9, and 10 years
Secondary Endpoint: Feasibility of re-TAVR based on CT scan evaluation (CT scan, for selected sites only)
Number of participants in whom redo-TAVR is deemed feasible based on CT scan evaluation. Feasibility will be assessed using predefined anatomical criteria, including: Annular dimensions Coronary access Valve frame interactions Need for leaflet modification techniques Feasibility will be categorized as: "Feasible without modification," "Feasible with modification," or "Not feasible.
Time frame: 1 month post procedure
Secondary Endpoint: Number of Participants Requiring New Permanent Pacemaker Implantation (PPI) Due to Conduction System Disturbances
Number of participants who require a new permanent pacemaker implantation (PPI) within 1 month post-procedure due to conduction system disturbances (e.g., high-degree atrioventricular block, left bundle branch block). Indications for PPI will be based on standard clinical guidelines.
Time frame: 1 month post procedure
Secondary Endpoint: Rate of prosthetic valve regurgitation (moderate or severe)
Time frame: 1 year post procedure
Secondary Endpoint: Number of Participants with Major Vascular Complications (VARC-3 Criteria)
Number of participants experiencing major vascular complications within 1 month post-procedure, as defined by VARC-3 criteria. o Scoring System: Valve Academic Research Consortium-3 (VARC-3) criteria o Definition: MAJOR vacular complication: One of the following: • Aortic dissection or aortic rupture • Vascular injury or compartment syndrome resulting in death,VARC type ≥2 bleeding, limb or visceral ischaemia, or irreversible neurologic impairment • Distal embolization (non-cerebral) from a vascular source resulting in death, amputation, limb or visceral ischaemia, or irreversible end-organ damage • Unplanned endovascular or surgical intervention resulting in death, VARC type ≥2 bleeding, limb or visceral ischaemia, or irreversible neurologic impairment • Closure device failure resulting in death, VARC type ≥2 bleeding, limb or visceral ischaemia, or irreversible neurologic impairment
Time frame: 1 month post procedure
Secondary Endpoint: Performance of the aortic valve : Gradients (mean/max) assessed by TTE
Mean and peak aortic valve gradients (mmHg) will be measured by transthoracic echocardiography (TTE) at each follow-up time point. Values will be reported as mean ± standard deviation (SD).
Time frame: 1 year and 3 years post procedure
Secondary Endpoint: Performance of the aortic valve : paravalvular leakage (PVL) grade evaluated by transthoracic echocardiogram (TTE)
Number of participants stratified by paravalvular leakage (PVL) grade (None, Mild, Moderate, Severe), as assessed by TTE. PVL severity will be determined based on echocardiographic parameters defined by the VARC-3 criteria.
Time frame: 1 year and 3 years post procedure
Secondary Endpoint: Performance of the aortic valve : effective orifice are (EOA) evaluated by transthoracic echocardiogram (TTE)
Effective orifice area (EOA) (cm²) measured using the continuity equation on TTE. Values will be reported as mean ± standard deviation (SD).
Time frame: 1 year and 3 years post procedure
Secondary Endpoint: Number of Participants with Structural Valve Deterioration (VARC-3) and/or Requiring Redo-TAVR or Valve Explantation
Number of participants experiencing significant structural valve deterioration (SVD) as defined by VARC-3 criteria. SVD will be assessed by transthoracic echocardiography (TTE) Number of participants requiring redo-TAVR or surgical valve explantation within 5 years and 10 years post-procedure.
Time frame: 5 years and 10 years post procedure
CT Scan Sub Study endpoints: Secondary outcomes : feasibility of redoTAVR or ViV TAVR with or without requiring leaflet modification techniques
Proportion of participants in whom redo-TAVR or ViV-TAVR is feasible, with or without requiring leaflet modification techniques, based on CT scan evaluation. Classification will be based on predefined anatomic and hemodynamic feasibility criteria.
Time frame: 1 month post procedure
CT Scan Sub Study endpoints: Secondary outcomes: prevalence of HALT in both TAVR and SAVR groups
Number of participants with HALT detected on CT scan in both TAVR and SAVR groups. HALT will be defined as the presence of hypo-attenuated leaflet thickening observed on post-procedure CT imaging.
Time frame: 1 month post procedure
CT Scan Sub Study endpoints: Secondary outcomes: Impact of HALT on Mean Transvalvular Gradient - Valve Hemodynamics
* Outcome Measure: Mean change in mean transvalvular gradient (mmHg) in participants with and without HALT, measured by transthoracic echocardiography (TTE). * Time Frame: 1 month post-procedure * Unit of Measure: mmHg * Interpretation: A higher mean transvalvular gradient suggests increased valve obstruction.
Time frame: 1 month post procedure
CT Scan Sub Study endpoints: Secondary outcomes: Impact of HALT on Peak Transvalvular Gradient - Valve Hemodynamics
* Outcome Measure: Mean change in peak transvalvular gradient (mmHg) in participants with and without HALT, measured by transthoracic echocardiography (TTE). * Time Frame: 1 month post-procedure * Unit of Measure: mmHg * Interpretation: A higher peak transvalvular gradient indicates greater hemodynamic burden on the valve.
Time frame: 1 month post procedure
CT Scan Sub Study endpoints: Secondary outcomes: Impact of HALT on Effective Orifice Area (EOA) - Valve Hemodynamics
* Outcome Measure: Mean change in effective orifice area (cm²) in participants with and without HALT, measured by transthoracic echocardiography (TTE). * Time Frame: 1 month post-procedure * Unit of Measure: cm² * Interpretation: A lower EOA suggests impaired valve opening and increased risk of stenosis.
Time frame: 1 month post procedure
CT Scan Sub Study endpoints: Secondary outcomes: Mean Transvalvular Gradient - THV Hemodynamics
* Outcome Measure: Mean transvalvular gradient (mmHg) measured by TTE post-implantation. * Time Frame: 1 month post-procedure * Unit of Measure: mmHg * Interpretation: Higher gradients indicate increased obstruction.
Time frame: 1 month post procedure
CT Scan Sub Study endpoints: Secondary outcomes: Peak Transvalvular Gradient - THV Hemodynamics
* Outcome Measure: Peak transvalvular gradient (mmHg) measured by TTE post-implantation. * Time Frame: 1 month post-procedure * Unit of Measure: mmHg * Interpretation: Higher peaks indicate more severe stenosis.
Time frame: 1 month post procedure
CT Scan Sub Study endpoints: Secondary outcomes: Effective Orifice Area (EOA) - THV Hemodynamics
* Outcome Measure: Effective orifice area (cm²) measured by TTE post-implantation. * Time Frame: 1 month post-procedure * Unit of Measure: cm²
Time frame: 1 month post procedure
CT Scan Sub Study endpoints: Secondary outcomes: Commissural Alignment of THV
Mean commissural misalignment angle (degrees) measured by CT scan to evaluate THV positioning relative to native aortic valve commissures.
Time frame: 1 month post procedure
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