An observational study in Aortic Valve Stenosis, sponsored by Meril Life Sciences Pvt. Ltd.. Recruiting at 8 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-04.
Sponsored by Meril Life Sciences Pvt. Ltd. · Observational
A retrospective, multinational, multicentre, observational study in patients presenting with native severe aortic valve stenosis and treated with Myval™ Transcatheter Heart Valve Series in real-world setting.
Myval Global Study: A retrospective, multicentre, observational study in patients presenting with native severe aortic valve stenosis and treated with Myval™ Transcatheter Heart Valve Series in real-world setting.
This study shall retrospectively collect the data of minimal 200 consecutive patients treated with Myval™ THV Series approximately 15 participating sites Globally.
Primary Endpoint:
Primary Combined Safety and Effectiveness Endpoint: [Time frame: 30 days]
It is the composite of following:
Secondary endpoints:
Functional improvement from baseline as measured per
a. NYHA functional classification [Time frame: Baseline, 30 days]
Echocardiographic End Points
Patient-prosthesis Mismatch: [Time Frame: Post-procedure, predishcarge, Through 30 days] Severity patient-prosthesis-mismatch will be based on following
Length of index hospital stay. [Time frame: At discharge]
Other Endpoints:
Interference with the LVOT [Time Frame: During procedure]
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.
985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.
This study's planned enrollment of 200 is close to the median of 200 across 424 observational studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →Meril Life Sciences Pvt. Ltd. is the lead sponsor of 13 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients who have been treated with Myval™ THV series will be selected for the study.
Exclusion Criteria:
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.
Also known as: Myval THV
Safety and Effectiveness as defined by the Valve Academic Research Consortium-3 (VARC-3)
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
Time frame: 30 day
All-cause mortality
Number of mortality as per VARC - 3 Criteria
Time frame: 30 day
All stroke
Time frame: Through 30 days
Acute Kidney Injury (AKI) based on the Acute Kidney Injury Network (AKIN) System Stage 2, Stage 3 or Stage 4
Number of participants of AKI as per AKIN Network
Time frame: Through 30 days
Bleeding type 3 and 4
Number of participants for bleeding as per VARC-3 criteria
Time frame: Through 30 days
Moderate or severe prosthetic valve regurgitation
Time frame: Through 30 days
New permanent pacemaker implantation
New permanent pacemaker implantation rates will be analyzed further based on the patient's history of left and/or right bundle branch block
Time frame: Through 30 days
Conduction disturbances and arrhythmias
Number of participants for Conduction disturbances and arrhythmias as per VARC-3 Criteria
Time frame: Through 30 days
Device Success
Number of participants for Device success as per VARC-3 Criteria
Time frame: 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-3 Criteria
Time frame: After 30 days of index procedure
Clinical efficacy after 30 days
Number of participants for Clinical efficacy as per VARC-2 Criteria
Time frame: After 30 days of index procedure
Time related valve safety
Number of participants for Time related valve safety as per VARC-2 Criteria
Time frame: Through 30 days
Vascular and access related complications
Number of participants for Vascular and access related complications as per VARC-3 Criteria
Time frame: Pre-discharge, Through 30 days
Major vascular complications
Number of participants for Major vascular complications as per VARC-3 Criteria
Time frame: Pre-discharge, Through 30 days
Functional improvement from baseline as measured
Number of participants for Functional improvement as per 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
Severity patient-prosthesis-mismatch will be based on following For subjects with BMI \< 30 kg/m2, index effective orifice area (EOAi) 0.85 - 0.66 cm2/m2 for moderate and ≤0.65 cm2/m2 for severe For subjects with BMI ≥30 kg/m2, index effective orifice area (EOAi) 0.70 - 0.56 cm2 /m2 for moderate and ≤0.55 cm2/m2 for severe BMI = weight(kg)/(height (m)) 2
Time frame: Through 30 days
Length of index hospital stay
Number of days from hospital admission to discharge
Time frame: At discharge
Re-hospitalization
Number of participants as per VARC-3 defined criteria
Time frame: Through 30 days
New onset of atrial fibrillation or atrial flutter
VARC-3 criteria
Time frame: Post-procedure, Pre-discharge and 30 days
Endocarditis
Number of participants for Endocarditis as per VARC-3 criteria
Time frame: Through 30 days
Major bleeding event
Number of participants for Major bleeding event as per VARC-3 criteria
Time frame: Through 30 days
Myocardial rupture
Number of participants for Myocardial rupture
Time frame: During procedure
Paravalvular Leak
Number of participants for Paravalvular Leak
Time frame: Through 30 days
Degree of over - or Under-expansion of Myval
Number of participants for Degree of over - or Under-expansion of Myval
Time frame: During Procedure
Accuracy of deployment in relation to the annular plane
Number of participants for Accuracy of deployment in relation to the annular plane
Time frame: During procedure
Pacemaker deployment (and the symptoms resulting in it)
Number of participants for Pacemaker deployment (and the symptoms resulting in it)
Time frame: Through 30 days
Interference with the mitral valve
Number of participants for Interference with the mitral valve
Time frame: During procedure
Interference with the LVOT
Number of participants for Interference with the LVOT
Time frame: During procedure
Plan to share: No
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Meril Life Sciences Pvt. Ltd.