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| ID | Type | Description | Link |
|---|---|---|---|
| ERP-2019-11795 | Other Grant/Funding Number | Medtronic |
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| Name | Class |
|---|---|
| Medtronic Cardiovascular | INDUSTRY |
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This study will analyze patients with aortic stenosis who have undergone transcatheter valve implantation and surgical aortic valve replacement. Afterwards, the results of these two procedures will be collected to the database and compared among the Kazakhstani population.
Primary Objectives
Study Design Registry, IV phase
Subject Follow-up Schedule Maximum follow-up is approximately 4 years.
Inclusion Criteria Patients have TAVI
Exclusion Criteria Patients have not TAVI
Primary Endpoints The database contains data on mortality, intraoperative complications, post-operative complications and adverse cardiovascular events. We will perform Quality of Life analysis before TAVI and one year later, using the Short-Form 36 (SF36) instrument on 70% of our patients.
Patient Safety The NRCCS is a leading center for interventional cardiology in Kazakhstan, and in Central Asia, performing a high volume of TAVI procedures annually
Procedure / Intervention Description
Secondary Endpoints
Statistical Method / Rationale Foundational work has been completed through our database development, but there is significant potential to expand our data collection to other Central Asian interventional cardiology centers. As technology evolves and options for trans-femoral TAVI approaches increase, the likelihood of using TAVI over SAVR will increase in Kazakhstan and Central Asia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients after transcatheter aortic valve replacement | Experimental | Patients after transcatheter aortic valve replacement We will compare TAVI with SAVR data on mortality, intraoperative complications, post-operative complications and adverse cardiovascular events. We will perform Quality of Life analysis before TAVI and one year later, using the Short-Form 36 (SF36) instrument on 70% of our patients. |
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| Patients after surgical aortic valve replacement | Active Comparator | Patients after surgical aortic valve replacement We will compare TAVI with SAVR data on mortality, intraoperative complications, post-operative complications and adverse cardiovascular events. We will perform Quality of Life analysis before TAVI and one year later, using the Short-Form 36 (SF36) instrument on 70% of our patients. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcatheter aortic valve implantation | Device | Compare self expendable and balloon expendable valves |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of death | 12 month all-cause of mortality | 1 year |
| Evaluate of echocardiographic results | echocardiographic parameters: Aortic valve orifice area, aortic valve bioprosthetic gradient (peak, mean), aortic valve bioprosthetic velocity, ejection fracrion of left ventricle (LVEF%). | 1 year |
| Incidence of stroke | procedure associated stroke and 12 months | within 30 days and 12 months |
| Permanent pacemaker implantation | procedure associated AB block which is need for permanent pacemaker implantation | within 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Life quality | Quality of life on 36-item short-form (SF 36) will be carry before and 12 months after the procedure | Baseline, 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Abdurashid Mussayev, PhD | Contact | +77029997667 | abdurashid.mussayev@gmail.com | |
| Sadyk Khamitov | Contact | +77055756439 | sadyk.kh@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Research Center for Cardiac Surgery | Recruiting | Astana | 010000 | Kazakhstan |
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|
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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| ID | Term |
|---|---|
| D065467 | Transcatheter Aortic Valve Replacement |
| ID | Term |
|---|---|
| D019918 | Heart Valve Prosthesis Implantation |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019919 | Prosthesis Implantation |
| D019616 | Thoracic Surgical Procedures |
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