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| Name | Class |
|---|---|
| CardioVascular Research Foundation, Korea | OTHER |
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This study is to evaluate the efficacy and safety of transcatheter aortic valve replacement (TAVR) in severe 'pure Aortic regurgitation (AR)' using Evolut R valve (Medtronic, Minneapolis, MN).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pure AR | Experimental | Patients with symptomatic severe aortic valve regurgitation without severe aortic stenosis requiring aortic valve replacement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAVR with Evolut R valve | Device | TAVR with Evolut R valve |
|
| Measure | Description | Time Frame |
|---|---|---|
| Aortic regurgitation | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| All cause death | 1 month, 6 months, 1,2,3 and 5 years | |
| Cardiovascular mortality | 1 month, 6 months, 1,2,3 and 5 years | |
| Stroke |
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Inclusion Criteria:
Patients must have co-morbidities such that the principal investigator and co-investigator concur that the predicted risk of operative mortality is ≥15% (STS score ≥10 OR Logistic EuroSCORE ≥20%).
A candidate who does not meet [the STS score criteria ≥ 10 OR Logistic EuroSCORE ≥20%] can be included in the study if a peer review by at least two investigators concluded and documented that the patient's predicted risk of operative mortality is ≥15% from old age, severe frailty or STS score ≥8. In this case, all evidence must be documented in the study case report form as well as in the patient medical record.
There is a formal agreement by a cardiac surgeon, echo part cardiologist and interventional cardiologist according to the relevant guideline.
The subject does not have severe degenerative aortic stenosis and do have severe aortic regurgitation.
The subject or the subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
The subject agrees that the subject will keep in touch with study team for all required post-procedures like angiography or transesophageal echography.
The subject agrees that the subject will cooperate with study team for all required post-procedure visits.
The subject's age is 20 or more.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | South Korea |
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| ID | Term |
|---|---|
| D001022 | Aortic Valve Insufficiency |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Valve Academic Research Consortium (VARC) |
| 1 month, 6 months, 1,2,3 and 5 years |
| Myocardial Infarction | Valve Academic Research Consortium (VARC) | 1 month, 6 months, 1,2,3 and 5 years |
| Re-hospitalization | 1 month, 6 months, 1,2,3 and 5 years |
| Acute kidney injury | Valve Academic Research Consortium (VARC) | 7 days |
| Vascular access site and access-related complication | Valve Academic Research Consortium (VARC) | 7 days |
| Bleeding | Valve Academic Research Consortium (VARC) | 7 days |
| Acute kidney injury | 7 days |