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Post Market Clinical follow up Study of TTK Chitra Heart Valves

Post Market Clinical follow up Study of TTK Chitra Heart Valves Model TC1 (PMCFU.2-TCHV-TC1) Prospective, Single-centre, Single arm, Clinical follow-up Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2015/08/006094
Enrollment
250
Registered
2015-08-13
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: Z952- Presence of prosthetic heart valve

Interventions

Intervention1: NIL (Not Applicable).: NIL (Not Applicable). Control Intervention1: NIL (Not Applicable).: NIL (Not Applicable).

Sponsors

Heart Valve Division TTK Healthcare Limited
Lead Sponsor
JSS Medical Research India Private Limited
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: a) Individuals at least 18 years old and able to give informed consent. b) Patient implanted with study device as per instructions for use during the said period. c) The patient (or legal guardian) has signed an informed consent, and agreeing to the data collection.

Exclusion criteria

Exclusion criteria: a) Patient implanted with any other valve apart from the study device. b) Any patient actively participating in any other study of an investigational drug or device to be excluded.

Design outcomes

Primary

MeasureTime frame
For details, please refer to the brief summary.Timepoint: For details, please refer to the brief summary.

Secondary

MeasureTime frame
Not Applicable.Timepoint: Not Applicable.

Countries

India

Contacts

Public ContactDr Shariq Anwar

TTK Healthcare Ltd.

rkn@ttkhealthcare.com04712707002

Outcome results

None listed

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