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| Name | Class |
|---|---|
| Danish Cardiovascular Academy (DCA) | UNKNOWN |
| Eva og Henry Frænkels Mindefond | OTHER |
| Snedkermester Sophus Jacobsen and hustru Astrid Jacobsens Foundation | OTHER |
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Background: Severe aortic valve stenosis (AS) is the commonest valve disease. Aortic valve replacement (AVR) is primarily indicated when symptoms occur and/or when there is a drop in left ventricular ejection fraction. However, irreversible myocardial damage, such as replacement fibrosis, leads to increased morbidity and mortality despite treatment. Improved patient selection and timely treatment is thus warranted. T1 mapping, a non-invasive method to quantify myocardial fibrosis by cardiac magnetic resonance (CMR), could be a marker to guide treatment.
Aims: To investigate the change of myocardial fibrosis* in AS patients following AVR and if these changes are associated with disease and/or procedural characteristics.
Methods: This is an observational clinical trial. Approximately 60 patients with severe AS planned to undergo AVR (either surgical or transcatheter) at Rigshospitalet, Denmark will be included. Participants will undergo CMR before surgery and at a 1-year follow-up. Other assessments include clinical evaluation and blood sampling. The primary end-point is change in T1 values after AVR.
Hypotheses and perspectives: The investigators hypothesize that (1) myocardial fibrosis* will regress in patients undergoing AVR as a group, (2) the degree of myocardial fibrosis is positively correlated with the degree of symptoms, (3) the regression of myocardial fibrosis is greater in patients undergoing TAVR compared to SAVR, and (4) the regression of myocardial fibrosis is greater in patients with tricuspid aortic stenosis compared to bicuspid aortic stenosis. Ultimately, T1 mapping is a potential marker for improved patient selection for the timing of AVR.
* Estimated by T1 mapping
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Severe aortic valve stenosis | Patients with severe AS, either symptomatic patients planned to undergo AVR as surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR), or asymptomatic patients managed with clinical surveillance. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aortic valve replacement | Procedure | SAVR or TAVR |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in T1 values from baseline to follow-up | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| New York Heart Association (NYHA) Classification | Through study completion, an average of 1 year | |
| Type of AVR | SAVR or TAVR | Through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Patients are recruited from Righospitalet, Denmark, when referred to AVR.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Copenhagen O | 2100 | Denmark |
Data can be provided upon request
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From study end
Researchers who provide a methodological sound proposal
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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 |
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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 |
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| Native valve | Bicuspid or tricuspid aortic valve | Through study completion, an average of 1 year |
| Left ventricular volumes | By cardiac magnetic resonance | Through study completion, an average of 1 year |
| Left ventricular mass | By cardiac magnetic resonance | Through study completion, an average of 1 year |
| Left ventricular strain | By cardiac magnetic resonance and echocardiography | Through study completion, an average of 1 year |
| Late gadolinium enhancement | By cardiac magnetic resonance | Through study completion, an average of 1 year |
| Extracellular volume | By cardiac magnetic resonance | Through study completion, an average of 1 year |
| Left ventricular ejection fraction | By cardiac magnetic resonance and echocardiography | Through study completion, an average of 1 year |
| Left atrial size | By cardiac magnetic resonance and echocardiography | Through study completion, an average of 1 year |
| e' velocity | By echocardiography | Through study completion, an average of 1 year |
| E/e' ratio | By echocardiography | Through study completion, an average of 1 year |
| Tricuspid regurgitation velocity | By echocardiography | Through study completion, an average of 1 year |
| Concentration of NT-Pro-BNP | Through study completion, an average of 1 year |
| Concentration of Troponin T | Through study completion, an average of 1 year |
| D014694 |
| Ventricular Outflow Obstruction |
| D019919 | Prosthesis Implantation |
| D019616 | Thoracic Surgical Procedures |