Health Condition 1: - Health Condition 2: I359- Nonrheumatic aortic valve disorder, unspecified
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
UNIMED HEALTH CARE PRIVATE LIMITED (STAR HOSPITALS)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants age must be 18 years. 2. Participants have been adequately informed of risks and requirements of the registry (which are actually limited since the prosthesis is in full commercial use and only data collection will be performed) and are willing to provide informed consent for participation in the registry. 3. Participants who have undergone aortic valve replacement surgery with implantation of the Avalus valve, as per clinical indication.
Exclusion criteria
Exclusion criteria: 1. Not been able to provide consent. 2. Had MRI or CT scan confirmed stroke, cerebrovascular accident, or TIA within 6 months (180 days) prior to planned valve surgery 3. Had the presence of non-cardiac disease, limiting life expectancy to less than 5 years 4. Diagnosed with hypertrophic obstructive cardiomyopathy. 5. Diagnosed with abnormal calcium metabolism and hyperparathyroidism 6. Exhibits left ventricular ejection fraction less than or equal to 20 percent as validated by diagnostic procedure prior to planned valve surgery. 7. Had presence of echocardiographic evidence of an intra-cardiac mass, thrombus, or vegetation 8. Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to planned valve surgery. 9. Underwent prior organ transplant or is currently an organ transplant candidate. 10. Currently participating in a study of an investigational drug or device. 11. Is pregnant (female participant of childbearing potential only), lactating, or planning to become pregnant during the duration of participation in study. 12. Had a documented history of substance (drug or alcohol) abuse within the last 5 years prior to implant material. 13. Required concomitant left ventricular assist device placement 14. Known hypersensitivity or contraindication to bivalirudin, nitinol, prasugrel, heparin, clopidogrel, acetyl salicylic acid, or contrast material.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| To evaluate procedural characteristics and surgical outcomes, including in complex and high-risk cases. To document echocardiographic outcomes, including hemodynamic parameters, at baseline, post procedure, and at 15-30 days and 12-15 months. To assess the incidence of specific adverse events, including mortality, stroke, re-hospitalization, and prosthetic valve-related complications, during in-hospital stay, at above specified timeframe. To evaluate participant quality of life (QoL) and other relevant clinical metrics in the specified timeframes. Timepoint: Baseline, Post-Procedure, 15-30 days, 12-15 months. | — |
Primary
| Measure | Time frame |
|---|---|
| To assess the real-world clinical outcomes and hemodynamic performance of the Avalus Pericardial Bioprosthesis in participants undergoing bioprosthetic AVR.Timepoint: Baseline, Post-Procedure, 15-30 days, 12-15 months. | — |
Countries
India
Contacts
Public ContactDr K H Ramanjaneya
STAR Hospitals
Outcome results
None listed