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Evaluating the Safety and Performance of the New Miltonia Heart Valve: One-Year Clinical Outcomes

Early Clinical Experience with the new Bi-Leaflet Miltonia Heart Valve: An One Year Prospective Follow Up Study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/06/112753
Enrollment
50
Registered
2026-06-15
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

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: Nil: Nil Control Intervention1: Nil: Nil

Sponsors

KLES Academy of Higher Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All Adult Patients of age more than 18 years who Shall to undergo single or double heart valve replacement like AVR, MVR, or DVR with the Miltonia bileaflet mechanical prosthesis. 2. Patients or legally authorized representatives who provide written informed consent for proposed-term follow-up.

Exclusion criteria

Exclusion criteria: 1. Patients lost to follow-up (i.e., status cannot be determined via clinical visit, telephonic contact, or government records). 2. Patients who refuse for Follow-Up.

Design outcomes

Primary

MeasureTime frame
To assess the haemodynamic performance of Miltonia valve in the aortic and mitral positions, specifically measuring the mean or peak transprosthetic gradients and effective orifice area.Timepoint: Baseline: At discharge 1 month: First follow up 6 months: Second follow up 1 year: Final follow up—

Secondary

MeasureTime frame
Actuarial survival ratesTimepoint: Baseline: At discharge 1 month: First follow up 6 months: Second follow up 1 year: Final follow up ;Freedom from Valve Related Morbidity: Thromboembolism, Hemorrhagic complications, Prosthetic valve endocarditis, structural valve deterioration, non structural valve deterioration stratified by implantation position.Timepoint: Baseline: At discharge 1 month: First follow up 6 months: Second follow up 1 year: Final follow up ;Identification of risk factors: Preoperative, Intraoperative, postoperative risk factors associated with valve related complications.Timepoint: Baseline: At discharge 1 month: First follow up 6 months: Second follow up 1 year: Final follow up—

Countries

India

Contacts

Public ContactNihal S Kiran

Jawaharlal Nehru Medical College KLES Academy of Higher Education & Research Belagavi

drdarshan_ds@yahoo.co.in9844173644

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026