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

Phase 4

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

• Registration Number: CTRI/2023/10/059323
• Lead Sponsor: Meril Diagnostics Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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

Study & Design

• Study Type: PMS
• Study Design: Not specified