Myval Global Study of Myval™ THV Series Implanted in Patients With Native Severe Aortic Valve Stenosis.
- Conditions
- Aortic Valve Stenosis
- Registration Number
- NCT04703699
- Lead Sponsor
- Meril Life Sciences Pvt. Ltd.
- Brief Summary
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.
- Detailed Description
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:
* All-cause mortality
* All stroke
* Bleeding (type 3 and 4)
* Acute kidney injury (stage 2 ,3 \& 4)
* Major vascular complications
* Moderate or severe prosthetic valve regurgitation
* Conduction system disturbances resulting in a new permanent pacemaker implantation.
Secondary endpoints:
1. All-cause mortality (VARC-3 defined criteria) \[Time Frame: Through 30 days\]
2. All stroke (VARC-3 defined criteria) \[Time Frame: Through 30 days\]
3. Acute Kidney Injury (AKI) based on the Acute Kidney Injury Network (AKIN) System Stage 2, Stage 3 or Stage 4 \[Time Frame: Through 30 days\]
4. Bleeding type 3 and 4 (VARC-3 criteria) \[Time Frame: Through 30 days\]
5. Moderate or severe prosthetic valve regurgitation \[Time Frame: Through 30 days\]
6. 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.
7. Conduction disturbances and arrhythmias according to VARC-3 \[Time Frame: Through 30 days\]
8. Device success (VARC-3 criteria) \[Time Frame: Pre-discharge\]
9. Early safety at 30 days (VARC-3 criteria) \[Time Frame: After 30 days of index procedure\]
10. Clinical efficacy after 30 days (VARC-2 criteria) \[Time Frame: After 30 days of index procedure\]
11. Time-related valve safety (VARC-2 criteria) \[Time Frame: Through 30 days\]
12. Vascular and access related complications (VARC-3 criteria) \[Time Frame: Pre-discharge, Through 30 days\]
13. Major vascular complications (VARC-3 criteria) \[Time Frame: Pre-discharge, Through 30 days\]
14. Functional improvement from baseline as measured per
a. NYHA functional classification \[Time frame: Baseline, 30 days\]
15. 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 \[Time frame: Through 30 days\]
16. 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 - 0.66 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
17. Length of index hospital stay. \[Time frame: At discharge\]
- Number of days from hospital admission to discharge.
18. Re-hospitalization (VARC-3 defined criteria) \[Time Frame: Through 30 days\]
19. New onset of atrial fibrillation or atrial flutter \[Time Frame: Post-procedure, Pre-discharge and 30 days\]
20. Endocarditis \[Time Frame: Through 30 days\]
21. Major bleeding event \[Time Frame: Through 30 days\]
22. 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- All patients of this study must have received Myval™ THV series for treatment of native severe aortic stenosis and completed a minimum of 30-day follow-up.
- No
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and Effectiveness as defined by the Valve Academic Research Consortium-3 (VARC-3) 30 day 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 Outcome Measures
Name Time Method Major vascular complications Pre-discharge, Through 30 days Number of participants for Major vascular complications as per VARC-3 Criteria
All-cause mortality 30 day Number of mortality as per VARC - 3 Criteria
Device Success During hospital stay or maximum of 7 days after index procedure, whichever is earlier. Number of participants for Device success as per VARC-3 Criteria
Endocarditis Through 30 days Number of participants for Endocarditis as per VARC-3 criteria
New permanent pacemaker implantation 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
Moderate or severe prosthetic valve regurgitation Through 30 days Time related valve safety Through 30 days Number of participants for Time related valve safety as per VARC-2 Criteria
Echocardiographic End Points Through 30 days] * 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 indexMajor bleeding event Through 30 days Number of participants for Major bleeding event as per VARC-3 criteria
All stroke Through 30 days Acute Kidney Injury (AKI) based on the Acute Kidney Injury Network (AKIN) System Stage 2, Stage 3 or Stage 4 Through 30 days Number of participants of AKI as per AKIN Network
Bleeding type 3 and 4 Through 30 days Number of participants for bleeding as per VARC-3 criteria
Functional improvement from baseline as measured Baseline, 30 days Number of participants for Functional improvement as per NYHA functional classification
Conduction disturbances and arrhythmias Through 30 days Number of participants for Conduction disturbances and arrhythmias as per VARC-3 Criteria
Early safety at 30 days After 30 days of index procedure Number of participants for Early safety as per VARC-3 Criteria
Clinical efficacy after 30 days After 30 days of index procedure Number of participants for Clinical efficacy as per VARC-2 Criteria
Vascular and access related complications Pre-discharge, Through 30 days Number of participants for Vascular and access related complications as per VARC-3 Criteria
Pacemaker deployment (and the symptoms resulting in it) Through 30 days Number of participants for Pacemaker deployment (and the symptoms resulting in it)
Patient-prosthesis Mismatch 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 - 0.66 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
Length of index hospital stay At discharge Number of days from hospital admission to discharge
Re-hospitalization Through 30 days Number of participants as per VARC-3 defined criteria
New onset of atrial fibrillation or atrial flutter Post-procedure, Pre-discharge and 30 days VARC-3 criteria
Paravalvular Leak Through 30 days Number of participants for Paravalvular Leak
Degree of over - or Under-expansion of Myval During Procedure Number of participants for Degree of over - or Under-expansion of Myval
Interference with the mitral valve During procedure Number of participants for Interference with the mitral valve
Myocardial rupture During procedure Number of participants for Myocardial rupture
Accuracy of deployment in relation to the annular plane During procedure Number of participants for Accuracy of deployment in relation to the annular plane
Interference with the LVOT During procedure Number of participants for Interference with the LVOT
Trial Locations
- Locations (8)
Hospital Universitario de Gran Canaria Dr. Negrin
🇪🇸Las Palmas De Gran Canaria, Spain
North Estonia Medical center
🇪🇪Tallinn, Estonia
University Medical Centre Ljubljana
🇸🇮Ljubljana, Slovenia
University of Gdansk
🇵🇱Gdańsk, Bażyńskiego, Poland
Amphia Ziekenhui
🇳🇱Breda, North Brabant, Netherlands
Clinical Institute Saint Ambrogio
🇮🇹Milano, Italy
Kocaeli University School of Medicine
🇹🇷Kocaeli, Turkey
Hospital Cliinico Univertistario de Valladolid
🇪🇸Valladolid, Spain