This study looks at how safe and effective the MILTONIA heart valve is for patients who have had surgery to replace their aortic or mitral heart valves.

An ambispective, multi-centre, single-arm study to evaluate the safety and performance of MILTONIA Mechanical Bi-Leaflet Heart Valve in patients who underwent native/prosthetic aortic and/or mitral valve replacement in a real-world setting. - MILTONIA

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2025/06/089665

Enrollment

300

Registered

2025-06-27

Start date

Unknown

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

Health Condition 1: I080- Rheumatic disorders of both mitraland aortic valves

Interventions

Intervention1: MILTONIA Mechanical Bi-Leaflet Heart Valve: MILTONIA Mechanical Bi-Leaflet Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aort

hence, the frequency is one-time, and the total duration refers to the lifelong function of the implanted valve. Control Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients between 18 to 80 years of age 2. Patients successfully implanted with MILTONIA Mechanical Bi-Leaflet Heart Valve from January 2024 3. Patient or his/her Legally Acceptable Representative (LAR) should provide informed consent for study participation as per applicable local requirements. 4. Patient has adequate echocardiographic images to measure hemodynamic performance

Exclusion criteria

Exclusion criteria: 1. Patients who are not willing to provide an informed consent form, or whose legal heirs object to their participation in the study 2. Any condition, which, in Investigator’s opinion would preclude safe participation of patients in the study

Design outcomes

Primary

Measure	Time frame
- Procedural mortality - Improvement in hemodynamic performance by measuring Effective Orifice Area (EOA), Mean gradient, Major paravalvular leakTimepoint: 30 days of procedure or discharge 6 month	—

Secondary

Measure	Time frame
1. All-cause Mortality 2. Stroke and Transient Ischemic Attack (TIA) 3. Valve Thrombosis 4. Conduction Disturbances and Arrhythmias 5. Major Paravalvular Leak 6. Acute Kidney Injury 7. Bleeding 8. Prosthetic Valve Endocarditis 9. Structural Valve Deterioration 10. Non-structural dysfunction 11. Re-intervention 12. Explant 13. All non-valve related Serious adverse events Timepoint: Time Frame: 30 days,6 months, 1 year and 2 years;Hemodynamic and functional outcome 1. Improvement in hemodynamic parameters 2. NYHA functional class statusTimepoint: Time Frame: Baseline, Discharge, 30 days, 6 months, 1 year and 2 years	—

Measure

Time frame

1. All-cause Mortality 2. Stroke and Transient Ischemic Attack (TIA) 3. Valve Thrombosis 4. Conduction Disturbances and Arrhythmias 5. Major Paravalvular Leak 6. Acute Kidney Injury 7. Bleeding 8. Prosthetic Valve Endocarditis 9. Structural Valve Deterioration 10. Non-structural dysfunction 11. Re-intervention 12. Explant 13. All non-valve related Serious adverse events Timepoint: Time Frame: 30 days,6 months, 1 year and 2 years;Hemodynamic and functional outcome 1. Improvement in hemodynamic parameters 2. NYHA functional class statusTimepoint: Time Frame: Baseline, Discharge, 30 days, 6 months, 1 year and 2 years

—

Countries

India

Contacts

Public ContactDr Ashok Thakkar

Meril Life Sciences Pvt.Ltd.

ashok.thakkar@merillife.com912603509400

Outcome results

None listed

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