TTK Chitra â?? Titanium Heart Valve (Model TC2) Clinical Pilot Study
- Conditions
- Health Condition 1: I00-I99- Diseases of the circulatory system
- Registration Number
- CTRI/2021/03/031906
- Lead Sponsor
- TTK HEALTHCARE LIMITED
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1 Patients belonging to the age group of 13 to 70
2 Patients entering the program should be willing and also cooperate with the follow up program
3 The patient or legal guardian has signed an informed consent, and agreeing to the data collection
4 Only single valve replacements will be included
5 Patients with class IV NYHA symptoms may be included at the discretion of the participating surgeon
1 Patients who require emergency valvular procedures shall not be included in the program
2 Patient having serious comorbidities like diabetes mellitus, peptic ulcer, coagulopathies, connective tissue disorders, tuberculosis, renal insufficiency, or a history of cerebrovascular accident or epilepsy are excluded from the study
3 Patient having major organ dysfunction pulmonary, renal etc shall not be included
4 Patient actively participating in the study of any other investigational device or drug
5 Patients with previous implantation of valve prostheses or annuloplasty ring
6 Patients with aneurysmal dilation or dissection of the ascending aortic wall
7 Patient with myocardial infarction less than 90 days before the planned valve implant surgery
8 Patients undergoing renal dialysis for chronic renal failure
9 Any other serious illness decided by the clinical investigator
10 Infection, autoimmune diseases or any other chronic disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method