To assess the safety and performance of the Myvalâ?¢ Transcatheter Heart Valve System (THV) in real-world settings.

A retrospective, multicentre, observational registry in patients treated with Myvalâ?¢ Transcatheter Heart Valve System in real-world settings. - Myval THV Registry

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2023/10/059323

Enrollment

146

Registered

2023-10-31

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I083- Combined rheumatic disorders of mitral, aortic and tricuspid valves

Interventions

Intervention1: TAVI - Transcatheter Aortic Valve Implantation: Transcatheter Aortic Valve Implantation will be performed by using Model 3 Transcatheter Heart Valve (Myval Inception) The study duration

Eligibility

Inclusion criteria

Inclusion criteria: Patients treated with the Myval THV system for the following conditions: Symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve or mitral valve Symptomatic heart disease due to failure of native bicuspid aortic valve Symptomatic heart disease due to failure of the pulmonic valve Patients with calcific native mitral valve stenosis with mitral annular calcification Patients with failing surgical rings in the mitral position with mitral regurgitation or stenosis Patients who underwent tricuspid valve replacement (valve-in-valve) or prior TV repair (valve-in-ring) Patients who underwent Transcatheter Pulmonary Valve Replacement in pre-stented Right Ventricular Outflow Track (RVOT).

Exclusion criteria

Exclusion criteria: As this is a retrospective review of data, there are no formal exclusion criteria for this study.

Design outcomes

Primary

Measure	Time frame
1. All-cause mortality 2. Device-related Re-Intervention/ReoperationTimepoint: at the time point of 30 days	—

Secondary

Measure	Time frame
1) All-cause mortality 2) Procedure or device-related serious adverse events 3) All stroke 4) Prosthetic valve regurgitation 5) Conduction disturbances & arrhythmias 6) Vascular and access related complications 7) Functional improvement from baseline as measured per New Permanent Pacemaker 8) Hemodynamic parameters Confidential and Proprietary availability in the patientâ??s records and evaluated as per the site of valve implantation 9) Length of index hospital stay Number of days from index procedure to discharge. 10) Endocarditis 11) Myocardial Infarction 12) Device-related Re-intervention/Reoperation 13) Bleeding 14) Device success Timepoint: 30 Days	—

Measure

Time frame

1) All-cause mortality 2) Procedure or device-related serious adverse events 3) All stroke 4) Prosthetic valve regurgitation 5) Conduction disturbances & arrhythmias 6) Vascular and access related complications 7) Functional improvement from baseline as measured per New Permanent Pacemaker 8) Hemodynamic parameters Confidential and Proprietary availability in the patientâ??s records and evaluated as per the site of valve implantation 9) Length of index hospital stay Number of days from index procedure to discharge. 10) Endocarditis 11) Myocardial Infarction 12) Device-related Re-intervention/Reoperation 13) Bleeding 14) Device success Timepoint: 30 Days

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Countries

India

Contacts

Public ContactDr Ashok Thakkar

Meril Life Sciences Pvt. Ltd.

ashok.thakkar@merillife.com912603052100

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026