Effects of Aortic Valve Replacement on Myocardial T1 Values in Severe Aortic Valve Stenosis

Study Overview
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Brief Summary
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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

Official Title
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Effects of Aortic Valve Replacement on Myocardial T1 Values in Severe Aortic Valve Stenosis

Conditions
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T1 Mapping, Aortic Valve Stenosis, Aortic Valve Replacement, Myocardial Fibrosis, Cardiac Magnetic Resonance

Intervention / Treatment
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* Procedure: Aortic valve replacement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Severe aortic valve stenosis (Vmax > 4 m/s and/or mean gradient >40 mmHg) Exclusion Criteria: Reduced left ventricular ejection fraction (<50%) More than mild left-sided valvular insufficiency Previous or planned primary coronary intervention (PCI) or coronary artery by-pass grafting (CABG) Persistent atrial fibrillation Contraindications for CMR (pregnancy, severe claustrophobia, magnetic metallic implants) Pacemaker/ICD

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Severe aortic valve stenosis<br>Patients with severe AS planned to undergo AVR, either as surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR). | Procedure: Aortic valve replacement<br>* SAVR or TAVR<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in T1 values from baseline to follow-up |  | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aortic Valve Stenosis, Aortic Valve Replacement, Myocardial Fibrosis, Cardiac Magnetic Resonance, T1 mapping