Myval European Study of Myval™ THV System Implanted in Patients With Native Severe Aortic Valve Stenosis.

Study Overview
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Brief Summary
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Myval European Study: A retrospective, multicentre, observational study in patients presenting with native severe aortic valve stenosis and treated with Myval™ Transcatheter Heart Valve System in real-world setting.

Detailed Description
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Myval European Study: A retrospective, multicentre, observational study in patients presenting with native severe aortic valve stenosis and treated with Myval™ Transcatheter Heart Valve System in real-world setting. This study shall retrospectively collect the data of minimum 200 consecutive patients treated with Myval THV system between 01-June-2019 to 30-June-2020 from approximately 15 participating sites in Europe. Primary Endpoint: Primary Combined Safety and Effectiveness Endpoint: [Time frame: 30 days] It is the composite of following: All-cause mortality All stroke (disabling and non-disabling) Life-threatening or disabling bleeding Acute kidney injury (stage 2 or 3) Major vascular complications Moderate or severe prosthetic valve regurgitation Conduction system disturbances resulting in a new permanent pacemaker implantation. Secondary endpoints: All-cause mortality (VARC-2 defined criteria) [Time Frame: Through 30 days] All stroke (disabling and non-disabling) [Time Frame: Through 30 days] Disabling stroke: an mRS score of 2 or more at 90 days and an increase in at least one mRS category from an individual's pre-stroke baseline Non-disabling stroke: an mRS score of 2 at 90 days or one that does not result in an increase in at least one mRS category from an individual's pre-stroke baseline Note: As per VARC-2, the assessment of the mRS should be done at all scheduled visits in a trial and at 90 days after the onset of any stroke. Acute Kidney Injury (AKI) based on the Acute Kidney Injury Network (AKIN) System Stage 3 (including renal replacement therapy) or Stage 2 [Time Frame: Through 30 days] Life-threatening or disabling bleeding (VARC-2 criteria) [Time Frame: Through 30 days] Moderate or severe prosthetic valve regurgitation [Time Frame: Through 30 days] New permanent pacemaker implantation [Time Frame: Through 30 days] New permanent pacemaker implantation rates will be analyzed further based on the patient's history of left and/or right bundle branch block. Conduction disturbances and arrhythmias according to VARC-2 [Time Frame: Through 30 days] Device success (VARC-2 criteria) [Time Frame: Pre-discharge] Early safety at 30 days (VARC-2 criteria) [Time Frame: After 30 days of index procedure] Clinical efficacy after 30 days (VARC-2 criteria) [Time Frame: After 30 days of index procedure] Time-related valve safety (VARC-2 criteria) [Time Frame: Through 30 days] Vascular and access related complications (VARC-2 criteria) [Time Frame: Pre-discharge, Through 30 days] Major vascular complications (VARC-2 criteria) [Time Frame: Pre-discharge, Through 30 days] Functional improvement from baseline as measured per a. NYHA functional classification [Time frame: Baseline, 30 days] Echocardiographic End Points Effective orifice area (EOA) Index effective orifice area (iEOA) Mean aortic valve gradient Peak aortic valve gradient Peak aortic velocity Transvalvular, paravalvular and total aortic regurgitation Left ventricular ejection fraction (LVEF) Valve calcification Cardiac output and cardiac index [Time frame: Through 30 days] Patient-prosthesis Mismatch: [Time Frame: Post-procedure, predishcarge, Through 30 days] Severity patient-prosthesis-mismatch will be based on following For subjects with BMI < 30 kg/m2, index effective orifice area (EOAi) 0.85 - 0.65 cm2 /m2 for moderate and <0.65 cm2 /m2 for severe For subjects with BMI ≥30 kg/m2, index effective orifice area (EOAi) 0.90 - 0.60 cm2 /m2 for moderate and <0.60 cm2 /m2 for severe BMI = weight(kg)/(height (m)) 2 Length of index hospital stay. [Time frame: At discharge] - Number of days from hospital admission to discharge. Hospitalization for valve-related symptoms or worsening congestive heart failure (New York Heart Association [NYHA] class III or IV) [Time Frame: Through 30 days] New onset of atrial fibrillation or atrial flutter [Time Frame: Post-procedure, Pre-discharge and 30 days] Endocarditis [Time Frame: Through 30 days] Major bleeding event [Time Frame: Through 30 days] Other Endpoints: Myocardial rupture [Time Frame: During procedure] Paravalvular leak [Time Frame:Through 30 days] Degree of over- or under-expansion of Myval [Time Frame: During procedure] Accuracy of deployment in relation to the annular plane [Time Frame: During procedure] Pacemaker deployment (and the symptoms resulting in it) [Time Frame: Through 30 days] Interference with the mitral valve; and [Time Frame: During procedure] Interference with the LVOT [Time Frame: During procedure] If the endpoint data is available through 1 year, it will also be collected and analyzed. Clinical efficacy data will be collected only for patients with availability of data after 30 days follow-up. Long term clinical follow up by telephonic interview will be conducted for all patients who have completed 30 days safety follow-up, at 1 year, 3 year and 5 years.

Official Title
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Myval European Study: A Retrospective, Multicentre, Observational Study in Patients Presenting With Native Severe Aortic Valve Stenosis and Treated With Myval™ Transcatheter Heart Valve System in Real-world Setting

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Device: Myval Transcatheter Heart Valve System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients of this study must have received Myval THV system for treatment of native severe aortic stenosis and meet all eligibility and treatment criteria as defined by Hospital Heart Team and or Treating TAVR operator. Exclusion Criteria: No

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Myval Transcatheter Heart Valve System|Myval™ THV is a newer-generation balloon-expandable THV characterized by a nickel-cobalt alloy frame composed of a single element - hexagon arranged in a hybrid honeycomb fashion.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Effectiveness as defined by the Valve Academic Research Consortium-2 (VARC-2) | It is the composite of following All-cause mortality All stroke (disabling and non-disabling) Life-threatening or disabling bleeding Acute kidney injury (stage 2 or 3) Major vascular complications Moderate or severe prosthetic valve regurgitation Conduction system disturbances resulting in a new permanent pacemaker implantation | 30 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | Number of mortality as per VARC - 2 Criteria | 30 day | 
| All stroke (disabling and non-disabling) | Number of participants as per following criteria. Disabling stroke: an mRS score of 2 or more at 90 days and an increase in at least one mRS category from an individual's pre-stroke baseline Non-disabling stroke: an mRS score of 2 at 90 days or one that does not result in an increase in at least one mRS category from an individual's pre-stroke baseline | Through 30 days | 
| Acute Kidney Injury (AKI) based on the Acute Kidney Injury Network (AKIN) System Stage 3 (including renal replacement therapy) or Stage 2 | Number of participants of AKI as per AKIN Network | Through 30 days | 
| Life-threatening or disabling bleeding | Number of participants for Life-threatening or disabling bleeding as per VARC-2 criteria | Through 30 days | 
| Moderate or severe prosthetic valve regurgitation | VARC -2 criteria | Through 30 days | 
| New permanent pacemaker implantation | Number of participants for New permanent pacemaker implantation rates will be analyzed further based on the patient's history of left and/or right bundle branch block. | Through 30 days | 
| Conduction disturbances and arrhythmias | Number of participants for Conduction disturbances and arrhythmias as per VARC-2 Criteria | Through 30 days | 
| Device Success | Number of participants for Device success as per VARC-2 Criteria | During hospital stay or maximum of 7 days after index procedure, whichever is earlier. | 
| Early safety at 30 days | Number of participants for Early safety as per VARC-2 Criteria | After 30 days of index procedure | 
| Clinical efficacy after 30 days | Number of participants for Clinical efficacy as per VARC-2 Criteria | After 30 days of index procedure | 
| Time related valve safety | Number of participants for Time related valve safety as per VARC-2 Criteria | Through 30 days | 
| Vascular and access related complications | Number of participants for Vascular and access related complications as per VARC-2 Criteria | Immediately after procedure, at 1 Month | 
| Major vascular complications | Number of participants for Major vascular complications as per VARC-2 Criteria | Immediately after procedure, at 1 Month | 
| Functional improvement from baseline as measured | Number of participants for Functional improvement as per NYHA functional classification | Baseline, 30 days | 
| Acceptability Echocardiographic End Points | Outcome measures will be: Effective orifice area (EOA) Index effective orifice area (iEOA) Mean aortic valve gradient Peak aortic valve gradient Peak aortic velocity Transvalvular, paravalvular and total aortic regurgitation Left ventricular ejection fraction (LVEF) Valve calcification Cardiac output and cardiac index | At 1 Month | 
| Patient-prosthesis Mismatch | Number of participants for Patient-prosthesis Mismatch as per VARC 2 criteria | At 1 Month | 
| Length of index hospital stay | Number of days from hospital admission to discharge | At 1 Month | 
| Hospitalization for valve-related symptoms or worsening congestive heart failure (New York Heart Association [NYHA] class III or IV) | As per NYHA criteria | Through 30 days | 
| New onset of atrial fibrillation or atrial flutter | VARC-2 criteria | At 1 Month | 
| Endocarditis | Number of participantsfor Endocarditis as per VARC-2 criteria | Through 30 days | 
| Major bleeding event | Number of participants for Major bleeding event as per VARC-2 criteria | Through 30 days | 
| Myocardial rupture | Number of participants for Myocardial rupture | During procedure | 
| Paravalvular Leak | Number of participants for Paravalvular Leak | Through 30 days | 
| Degree of over - or Under-expansion of Myval | Number of participants for Degree of over - or Under-expansion of Myval | During Procedure | 
| Accuracy of deployment in relation to the annular plane | Number of participants for Accuracy of deployment in relation to the annular plane | During procedure | 
| Pacemaker deployment (and the symptoms resulting in it) | Number of participants for Pacemaker deployment (and the symptoms resulting in it) | Through 30 days | 
| Interference with the mitral valve | Number of participants for Interference with the mitral valve | During procedure | 
| Interference with the LVOT | Number of participants for Interference with the LVOT | During procedure |