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slow accrual
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The purpose of this study is to look at liver stiffness with a MRI sequence called Magnetic Resonance Elastography (MRE). The study will let the investigators know whether the subject's liver is normal or has increased stiffness. Increased liver stiffness often means there is chronic liver disease and fibrosis. Increased right heart pressure and congestive heart failure are considered risk factors for development of liver fibrosis. Liver fibrosis, if progressive, may lead to cirrhosis and its related complications. The increased liver stiffness may be due to a poorly functioning tricuspid valve. With this research, the investigators will be able to determine if the elevated stiffness of the liver returns to normal after the surgeon performs a repair or replacement of the tricuspid valve.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tricuspid Valvular Repair Patients | Experimental | Subjects will receive an MRI sequence called Magnetic Resonance Elastography (MRE) within 1 month preoperatively and as close to 6 months postoperatively as reasonably achievable. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI | Device | Subjects will receive an MRI sequence called Magnetic Resonance Elastography (MRE). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in liver stiffness between preoperative and postoperative MR elastography (MRE) | Increased liver stiffness often means there is chronic liver disease and fibrosis. | baseline, approximately 6 months postoperatively |
| Change in tricuspid valve regurgitation measured by echocardiography | Increased liver stiffness may be due to a poorly functioning tricuspid valve. | baseline, approximately 6 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Subject Functional Capacity | Subject Functional Capacity will be measured by the Self Assessment New York Heart Association (NYHA) Classification Scale. This questionnaire consists of 4 questions regarding the subject's ability to carry on physical activities. NYHA Class I = no symptoms in regular activity; NYHA Class II = Mild symptoms and slight limitation; NYHA Class III = noticeable limitations even during minimal activity; NYHA Class IV = severe limitations even while at rest. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael L Wells | Mayo Clinic | Principal Investigator |
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| ID | Term |
|---|---|
| D014262 | Tricuspid Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| baseline, approximately 6 months postoperatively |