Health Condition 1: I00-I99- Diseases of the circulatory system
Conditions
Interventions
Intervention1: Heart Valve Replacement Surgery: Replacement of diseased or damaged single aortic or mitral heart valve
Control Intervention1: Not applicable as this is a Single arm trial: Not applicab
Sponsors
TTK HEALTHCARE LIMITED
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SAFETY 1 Structural dysfunction of the valve Valve Related Adverse Events 1 Thrombosis, 2 Thromboembolism, 3 Major Hemorrhage, 4 Major Paravalular leak, 5 Hemolysis and 6 Endocarditis Performance 1 Valve gradients or EOA by Echocardiography and 2 Improvement in NHYA classificationTimepoint: 1 month 3 month 6 month 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| All non valve related adverse eventsTimepoint: 1 month 3 month 6 month 1 year | — |
Countries
India
Contacts
Public ContactK Sunil
Independent Technical Consultant to TTK
Outcome results
None listed