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The goal of this observational study is to learn about the long-term effects of aortic valve annular calcification in patients undergoing transcatheter aortic valve replacement (TAVR). The main question it aims to answer is:
Does the degree of aortic valve annular calcification prior to TAVR influence long-term clinical outcomes, including major adverse cardiovascular events including all-cause mortality, over a 3-year period?
Participants who have undergone TAVR as part of their regular medical care for severe aortic stenosis will have their pre-procedural imaging and clinical outcomes evaluated for a 3-year follow-up period.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcatheter aortic valve replacement with ballon-expandable or self-expandable valves | Device | Device: Edwards SAPIEN 3 valve, Medtronic Evolut valve, Boston Acurate Neo valve, or Abbott Navitor Access route: transfemorak, subclavian, transapical, transcarotid, or transcaval The use of balloon dilation will be left to the discretion of the operator. |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | 3 years follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalization for heart failure | 3 years follow-up | |
| Stroke | 3 years follow-up | |
| Myocardial infarction |
| Measure | Description | Time Frame |
|---|---|---|
| Echo parameters | annual follow-up until 3 years |
Inclusion Criteria:
Exclusion Criteria:
1. Individuals who have not provided written informed consent for this study.
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Adults aged 19 years or older who have undergone transcatheter aortic valve replacement (TAVR) for severe aortic stenosis and have voluntarily expressed their willingness to participate through written informed consent.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Osung Kwon, MD. PhD | Contact | +82-10-3708-5673 | oscaesar@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Cardiology, Department of Internal Medicine, Eunpyeong St. Mary's Hospital, College of Medicine, The Catholic University of Korea | Recruiting | Seoul | 122-200 | South Korea |
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| 3 years follow-up |
| Permanent pacemaker insertion | 3 years follow-up |
| Vascular complication | 30 days follow-up |
|
| 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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