Myval Global Study of Myval™ THV Series Implanted in Patients With Native Severe Aortic Valve Stenosis.

Aortic Valve Stenosis Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04703699
• Other study ID #: MLS/MYV-3/Global study
• Status: Recruiting
• Start date: August 7, 2020
• Est. completion date: November 30, 2028

Study information

• Verified date: February 2024
• Source: Meril Life Sciences Pvt. Ltd.
• Contact: Ashok Thakkar, Ph.D.
• Phone: +91-260-3063880
• Email: Ashok.Thakkar[@]merillife.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 30, 2028
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Device:
• Myval Transcatheter Heart Valve Series
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.

Locations

Country	Name	City	State
Estonia	North Estonia Medical center	Tallinn
Italy	Clinical Institute Saint Ambrogio	Milano
Netherlands	Amphia Ziekenhui	Breda	North Brabant
Poland	University of Gdansk	Gdansk	Bazynskiego
Slovenia	University Medical Centre Ljubljana	Ljubljana
Spain	Hospital Universitario de Gran Canaria Dr. Negrin	Las Palmas De Gran Canaria
Spain	Hospital Cliinico Univertistario de Valladolid	Valladolid
Turkey	Kocaeli University School of Medicine	Kocaeli

Sponsors (1)

Lead Sponsor	Collaborator
Meril Life Sciences Pvt. Ltd.

Countries where clinical trial is conducted

Estonia,  Italy,  Netherlands,  Poland,  Slovenia,  Spain,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	30 day
Secondary	All-cause mortality	Number of mortality as per VARC - 3 Criteria	30 day
Secondary	All stroke		Through 30 days
Secondary	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	Through 30 days
Secondary	Bleeding type 3 and 4	Number of participants for bleeding as per VARC-3 criteria	Through 30 days
Secondary	Moderate or severe prosthetic valve regurgitation		Through 30 days
Secondary	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	Through 30 days
Secondary	Conduction disturbances and arrhythmias	Number of participants for Conduction disturbances and arrhythmias as per VARC-3 Criteria	Through 30 days
Secondary	Device Success	Number of participants for Device success as per VARC-3 Criteria	During hospital stay or maximum of 7 days after index procedure, whichever is earlier.
Secondary	Early safety at 30 days	Number of participants for Early safety as per VARC-3 Criteria	After 30 days of index procedure
Secondary	Clinical efficacy after 30 days	Number of participants for Clinical efficacy as per VARC-2 Criteria	After 30 days of index procedure
Secondary	Time related valve safety	Number of participants for Time related valve safety as per VARC-2 Criteria	Through 30 days
Secondary	Vascular and access related complications	Number of participants for Vascular and access related complications as per VARC-3 Criteria	Pre-discharge, Through 30 days
Secondary	Major vascular complications	Number of participants for Major vascular complications as per VARC-3 Criteria	Pre-discharge, Through 30 days
Secondary	Functional improvement from baseline as measured	Number of participants for Functional improvement as per NYHA functional classification	Baseline, 30 days
Secondary	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	Through 30 days]
Secondary	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	Through 30 days
Secondary	Length of index hospital stay	Number of days from hospital admission to discharge	At discharge
Secondary	Re-hospitalization	Number of participants as per VARC-3 defined criteria	Through 30 days
Secondary	New onset of atrial fibrillation or atrial flutter	VARC-3 criteria	Post-procedure, Pre-discharge and 30 days
Secondary	Endocarditis	Number of participants for Endocarditis as per VARC-3 criteria	Through 30 days
Secondary	Major bleeding event	Number of participants for Major bleeding event as per VARC-3 criteria	Through 30 days
Secondary	Myocardial rupture	Number of participants for Myocardial rupture	During procedure
Secondary	Paravalvular Leak	Number of participants for Paravalvular Leak	Through 30 days
Secondary	Degree of over - or Under-expansion of Myval	Number of participants for Degree of over - or Under-expansion of Myval	During Procedure
Secondary	Accuracy of deployment in relation to the annular plane	Number of participants for Accuracy of deployment in relation to the annular plane	During procedure
Secondary	Pacemaker deployment (and the symptoms resulting in it)	Number of participants for Pacemaker deployment (and the symptoms resulting in it)	Through 30 days
Secondary	Interference with the mitral valve	Number of participants for Interference with the mitral valve	During procedure
Secondary	Interference with the LVOT	Number of participants for Interference with the LVOT	During procedure