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The purpose of this study is to characterize pulmonary hemodynamic profiles, with a focus on PVR subtypes, in patients with left-sided valvular heart disease undergoing aortic or mitral valve intervention, and to identify patterns predicting reversibility of TR and RV dysfunction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aortic Intervention |
| ||
| Mitral Intervention |
| ||
| Tricuspid intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Echocardiogram | Diagnostic Test | An echocardiogram will be performed during the patient's routinely scheduled right heart catheterization. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tricuspid Regurgitation (TR) reduction | Tricuspid Regurgitation (TR) reduction will be defined as ≥1 grade reduction | Baseline, 12 months |
| Right Ventricular function improvement | Right Ventricular function improvement will be defined as ≥5% in Right Ventricular free wall longitudinal strain | Baseline, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Hospitalizations | Number of Hospitalizations will be determined by the number of patients admitted to the hospital post procedure | 12 months |
| Number of Deaths | Number of Death will be determined by the number of patients that pass away post procedure due to any cause |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will consist of patients scheduled to undergo transcatheter aortic, mitral, or tricuspid valve interventions at Mayo Clinic Rochester.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Annabelle Fuenffinger | Contact | 507-422-3801 | fuenffinger.annabelle@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Barry Borlaug, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D004452 | Echocardiography |
| ID | Term |
|---|---|
| D057791 | Cardiac Imaging Techniques |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| 12 months |
| Kansas City Cardiomyopathy Questionnaire (KCCQ) | KCCQ is a 12-item questionnaires that measure the participant's perception of their health status, including their heart failure (HF) symptoms, impact on physical and social function and how their HF impacts the quality of life. Scores were generated for each domain and scaled from 0 to 70, with 0 (worst) and 70 (the best possible status), where the higher score reflected better health status. | Baseline, 6 months, and 12 months |
| Right atrial area change | Right atrial area change is used to assess right vascular function. It will measure the area of change within the right ventricle between diastole and systole as a percentage. | Baseline |
| Tricuspid annular plane systolic excursion (TAPSE) | Tricuspid annular plane systolic excursion will be used to measure right ventricular function and measured in mm (millimeters) | Baseline |
| D014463 | Ultrasonography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |