Post Market Clinical follow up Study of TTK Chitra Heart Valves (ModelTC1)

Post Market Clinical follow-up study of TTK Chitra Heart Valves (ModelTC1)Prospective, Single-centre, Single arm, Clinical follow-up Study - TCHV Study

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2013/11/004123

Enrollment

275

Registered

2013-11-01

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: null- Patient treated with TTK Chitra Heart Valve (model TC1).

Interventions

None listed

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 1st March 2005 to 29th February 2012. 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)Patient is actively participating in the study of an investigational drug or device.

Design outcomes

Primary

Measure	Time frame
The out come assessed from this Post Marketing - Clinical follow-up Study is Safety and effectiveness of the TTK Chitra Heart Valve by establishing the following: â?? Adverse event rates â?? Clinical status as indicated by NYHA functional classification â?? Hemodynamic performance Timepoint: Not applicable for this study as the outcome is measured on the day of patient enrolment and no further patient follow-up is required.	—

Measure

Time frame

The out come assessed from this Post Marketing - Clinical follow-up Study is Safety and effectiveness of the TTK Chitra Heart Valve by establishing the following: â?? Adverse event rates â?? Clinical status as indicated by NYHA functional classification â?? Hemodynamic performance Timepoint: Not applicable for this study as the outcome is measured on the day of patient enrolment and no further patient follow-up is required.

—

Secondary

Measure	Time frame
No any secondary outcome measured in this study.Timepoint: Not applicable	—

Countries

India

Contacts

Public ContactMr Rajiv Nair

TTK Healthcare Ltd

rkn@ttkhealthcare.com04712707002

Outcome results