Post Market Clinical follow up Study of TTK Chitra Heart Valves (ModelTC1)
Phase 4
- Conditions
- Health Condition 1: null- Patient treated with TTK Chitra Heart Valve (model TC1).
- Registration Number
- CTRI/2013/11/004123
- Lead Sponsor
- TTK Healthcare Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 275
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
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.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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: <br/ ><br>â?? Adverse event rates <br/ ><br>â?? Clinical status as indicated by NYHA functional classification <br/ ><br>â?? Hemodynamic performance <br/ ><br>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 Outcome Measures
Name Time Method o any secondary outcome measured in this study.Timepoint: Not applicable