Clinical trial NCT04703699: Myval Global Study of Myval™ THV Series Implanted in Patients With Native Severe Aortic Valve Stenosis.
Official title: 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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Valve Stenosis
Lead sponsor: Meril Life Sciences Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2021-01-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who have been treated with Myval™ THV series will be selected for the study.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* No

Primary outcomes:
measure: Safety and Effectiveness as defined by the Valve Academic Research Consortium-3 (VARC-3)
timeFrame: 30 day
Secondary outcomes:
measure: All-cause mortality
timeFrame: 30 day
measure: All stroke
timeFrame: Through 30 days
measure: Acute Kidney Injury (AKI) based on the Acute Kidney Injury Network (AKIN) System Stage 2, Stage 3 or Stage 4
timeFrame: Through 30 days
measure: Bleeding type 3 and 4
timeFrame: Through 30 days
measure: Moderate or severe prosthetic valve regurgitation
timeFrame: Through 30 days
measure: New permanent pacemaker implantation
timeFrame: Through 30 days
measure: Conduction disturbances and arrhythmias
timeFrame: Through 30 days
measure: Device Success
timeFrame: During hospital stay or maximum of 7 days after index procedure, whichever is earlier.
measure: Early safety at 30 days
timeFrame: After 30 days of index procedure
measure: Clinical efficacy after 30 days
timeFrame: After 30 days of index procedure
measure: Time related valve safety
timeFrame: Through 30 days
measure: Vascular and access related complications
timeFrame: Pre-discharge, Through 30 days
measure: Major vascular complications
timeFrame: Pre-discharge, Through 30 days
measure: Functional improvement from baseline as measured
timeFrame: Baseline, 30 days
measure: Echocardiographic End Points
timeFrame: Through 30 days]
measure: Patient-prosthesis Mismatch
timeFrame: Through 30 days
measure: Length of index hospital stay
timeFrame: At discharge
measure: Re-hospitalization
timeFrame: Through 30 days
measure: New onset of atrial fibrillation or atrial flutter
timeFrame: Post-procedure, Pre-discharge and 30 days
measure: Endocarditis
timeFrame: Through 30 days
measure: Major bleeding event
timeFrame: Through 30 days
measure: Myocardial rupture
timeFrame: During procedure
measure: Paravalvular Leak
timeFrame: Through 30 days
measure: Degree of over - or Under-expansion of Myval
timeFrame: During Procedure
measure: Accuracy of deployment in relation to the annular plane
timeFrame: During procedure
measure: Pacemaker deployment (and the symptoms resulting in it)
timeFrame: Through 30 days
measure: Interference with the mitral valve
timeFrame: During procedure
measure: Interference with the LVOT
timeFrame: During procedure
Other outcomes:
Locations:
city: Tallinn
country: Estonia
facility: North Estonia Medical center
city: Milano
country: Italy
facility: Clinical Institute Saint Ambrogio
city: Breda
country: Netherlands
facility: Amphia Ziekenhui
state: North Brabant
city: Gdańsk
country: Poland
facility: University of Gdansk
state: Bażyńskiego
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana
city: Las Palmas De Gran Canaria
country: Spain
facility: Hospital Universitario de Gran Canaria Dr. Negrin
city: Valladolid
country: Spain
facility: Hospital Cliinico Univertistario de Valladolid
city: Kocaeli
country: Turkey
facility: Kocaeli University School of Medicine
Study officials:
affiliation: Head - Clinical Research and Medical Writing
name: Ashok Thakkar, Ph.D.
role: STUDY_CHAIR
References: