Better Patient Selection to Transcatheter Aortic Valve Implantation

Study Overview
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Brief Summary
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This study evaluates whether a preoperative assessment of myocardial contractile reserve by tissue Doppler Imaging and myocardial fibrosis by cardiac magnetic resonance imaging (MRI) can enhance the patient selection and risk stratification to transcatheter aortic valve implantation.

Detailed Description
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In this prospective observation study we will investigate whether a preoperative test of myocardial contractile reserve can predict adverse outcome after TAVI. We intend to examine preoperative myocardial contractile reserve by use a low dose dobutamine test and relate this to pre-existing myocardial focal and diffuse myocardial fibrosis detected by new cardiac magnetic resonance imaging (MRI) methods and new echocardiographic methods. These measures will be primarily related to long term (12 months) mortality.

Official Title
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Better Patient Selection to Transcatheter Aortic Valve Implantation

Conditions
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Aortic Valve Stenosis, Left Ventricular Dysfunction, Myocardial Fibrosis

Intervention / Treatment
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* Diagnostic Test: Dobutamine stress test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients declined surgical aortic valve replacement and scheduled for transfemoral aortic valve implantation. Exclusion Criteria: Aortic valve endocarditis aortic annulus >31mm preoperative pacemaker severe aortic insufficiency (>grad 3) rapid atrial fibrillation unprotected left main coronary stenosis not suitable for percutaneous intervention. unstable angina life expectancy less than 12 months mental disorder including dementia and condition which interferes with protocol compliance. renal failure (glomerular filtration rate < 45 ml/min/m2), only have T1 mapping by CMRI. Patients with metal not suitable for MRI.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Preoperative myocardial reserve yes/no<br>Patients with extensive myocardial fibrosis typically presents with limited myocardial contractile reserve that can be assessed by a dobutamine stress test. The patients will be allocated to a responder and non-responder group according to the results from this test. | Diagnostic Test: Dobutamine stress test<br>* Test of myocardial reserve<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE | MACE at 12 months follow-up after TAVI, MACE definition: rehospitalization for heart failure or other valve related complications, nonfatal myocardial infarction, nonfatal stroke, or (cardiovascular) death | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NYHA functional classification of heart failure, Lack of improvement and/ or function class III or IV 12 months after the procedure defined unfavorable outcome | Number of Participants hospitalizated for heart related diseases during 12 month follow-up. | 1 year | 
| Patient quality of life (QoL) | Quality of life record (SF 36), Physical function (age adjusted normal value 71.6 (SD 26.9)) and Physical role (age adjusted normal value 57.0 (SD 43.8)) , the patients were divided into groups using the predefined minimal change of 15 and 18,75 points, respectively. Changes above these tresholds at 12 month follow-up indicat better QoL outcomes. | 1 year | 
| 6 Minute Walking Test | Favorable outcome defined as improvement in walking distance of 30 meters or longer at one year follow up. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myocardial fibrosis, Aortic Valve Stenosis, TAVI, Outcome