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Post Market Clinical Follow-up Study of CardiaMed Prosthetic Heart Valve

POST MARKET CLINICAL FOLLOW UP STUDY OF CARDIAMED PROSTHETIC HEART VALVE - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/09/094601
Enrollment
50
Registered
2025-09-11
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

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: Nil: Nil Intervention2: Nil: Nil Intervention3: Nil: Nil

Sponsors

TTK HEALTHCARE LIMITED
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: patients undergoing isolated valvular surgery.

Exclusion criteria

Exclusion criteria: Patients who have undergone any other type of open heart surgery along with valve will be excluded. also ,if patients have died during this span post surgery are excluded.

Design outcomes

Primary

MeasureTime frame
The objective of this study is to assess continued safety and effectiveness of the CardiaMed Prosthetic Heart Valve. The ACCEPTANCE HYPOTHESIS is that the adverse events or true rate of complications associated with the CardiaMed Prosthetic heart Valves are less than two times the Objective Performance Criteria (OPCs) specified in the international standard ISO 5840-2:2021.Timepoint: The outcome is to look into the results post surgery at the end of 1 month.—

Secondary

MeasureTime frame
nilTimepoint: nil—

Countries

India

Contacts

Public ContactHeli Oza

Seth GS Medical College and KEM Hospital

heli1992@gmail.com9619381403

Outcome results

None listed

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