Post Market Clinical follow up Study of TTK Chitra Heart Valves
Phase 4
Completed
- Conditions
- Health Condition 1: Z952- Presence of prosthetic heart valve
- Registration Number
- CTRI/2015/08/006094
- Lead Sponsor
- Heart Valve Division TTK Healthcare Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 250
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
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.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method