Health Condition 1: null- Aortic Valve failure
Conditions
Interventions
Intervention1: Trifecta Valve: Patients successfully implanted with Trifecta valve will be approached for participation.
Control Intervention1: Not Applicable: Not Applicable
Sponsors
St Jude Medical India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subject successfully implanted with SJM TrifectaTM Valve within the last 7 days. 2. Subject (or legal guardian) has given written informed consent for participation prior to enrollment 3. Subject is willing to undergo all study procedures and adhere to data collection and follow-up requirements 4. Subject has adequate echocardiographic images to measure hemodynamic performance of the SJM TrifectaTM valve.
Exclusion criteria
Exclusion criteria: 1. Subject requires replacement of the mitral, tricuspid or pulmonary valve or has a pre-existing prosthetic valve 2. Subject undergoing renal dialysis 3. Subject has an active endocarditis (Subjects with previous endocarditis must have two documented negative blood culture results prior to enrollment) 4. Subject is currently participating in the study of an clinical investigational drug or device 5. Preoperative evaluation indicated other significant cardiovascular abnormalities such as aortic dissection or ventricular aneurysm. 6. Subject is pregnant or planning to become pregnant during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the hemodynamic performance of the Trifectaâ?¢ valve as per the echocardiography parameters. The Mean, standard deviation, minimum and maximum values for mean gradient, peak gradient, effective orifice area, effective orifice area index, cardiac output, cardiac index, and performance index. The incidence/severity of aortic insufficiency (Percentage of subjects) as determined by echocardiography by location (central and paravalvular leak) will also be collected and recorded.Timepoint: 12 Months | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Percentage of subjects in each NYHA functional classification at baseline (preoperatively) and at follow-up intervals, changes in their NYHA functional classification status - the percentage of subjects improving, not changing, or worsening in NYHA functional classification at each follow-up time point. â?¢ Proportion of structural valve deterioration â?¢ Adverse events during the follow up period Timepoint: 12 Months | — |
Countries
India
Contacts
Public ContactSumit Anand
St. Jude Medical India Pvt. Ltd
Outcome results
None listed