Better Patient Selection to Transcatheter Aortic Valve Implantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

103 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-26

Study Completion Date

2021-03-31

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.

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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.

Conditions

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Aortic Valve Stenosis Left Ventricular Dysfunction Myocardial Fibrosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Preoperative myocardial reserve yes/no

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.

Dobutamine stress test

Intervention Type DIAGNOSTIC_TEST

Test of myocardial reserve

Interventions

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Dobutamine stress test

Test of myocardial reserve

Intervention Type DIAGNOSTIC_TEST

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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No