Transcatheter Aortic Valve Implantation in Western NORway

Study Overview
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Brief Summary
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A prospective study of 600 patients with severe aortic stenosis (AS) and symptoms who underwent TAVI at the Haukeland university hospital, Bergen, Norway.

Detailed Description
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A prospective study of 600 patients with severe aortic stenosis (AS) and symptoms who underwent TAVI at the Haukeland university hospital, Bergen, Norway between January 2012 and July 2019. Demographics, clinical data including cardiovascular risk factors, arterial and echocardiographic parameters were prospectively collected. The data on all-cause mortality will be collected. Echocardiograms (immediate before TAVI, at discharge after TAVI and at 6-12 months follow-up) will be analyzed. The main scientific objectives are: To assess survival benefits of TAVI according to baseline risk profile. To determine the echocardiographic predictors of left ventricular mass regression and left ventricular function recovery. To evaluate global LV load (Zva=valvular-arterial impedance) following TAVI. To assess the impact of various types of blood pressure responses immediately after TAVI on clinical outcomes.

Official Title
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The Impact of Transcatheter Aortic Valve Implantation on Left Ventricular Structure, Function and Outcome in Patients With Aortic Stenosis

Conditions
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Aortic Stenosis, Hypertension

Intervention / Treatment
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* Device: Biological prosthesis in the aortic valve


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hemodynamically severe aortic stenosis and symptoms A decision of TAVI by Heart team Patients undergoing TAVI (transcatheter aortic valve implantation) Life expectancy > 1-2 years Exclusion Criteria: Sever frailty Severly reduced cognitive function Multiple comorbid conditions Technically not suited for TAVI

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 |
| --- | --- |
| Only one arm (intervention=TAVI)<br>There is not control group/arm for comparison. | Device: Biological prosthesis in the aortic valve<br>* Transcatheter aortic valve implantation of bioprosthesis in patients with severe symptomatic aortic stenosis (clinically indicated)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The impact of TAVI on all-cause mortality | To assess the long-term survival benefits of TAVI | From January 2012 to Mai 2020 (date for assesment vital status) + prolonged follow-up (up to 10 years) | 
| The impact of TAVI on left ventriclar mass and hypertrophy regression | To assess whether removal of valve stenosis by TAVI leads to regression of left ventricular mass (grams). | From January 2012 to follow-up echo (6-12 months following TAVI) | 
| The impact of TAVI on left ventricular function recovery | To assess improvement in systolic function (increase in ejection fraction) following TAVI | From January 2012 to to follow-up echo (6-12 months following TAVI) | 
| The impact of TAVI on arterial load (systemic arterial stiffness and arterial compliance). | To assess improvement in echocardiographic arterial stiffness and arterial compliance and global left ventricular load (Zva=valvular-arterial impedance) following TAVI. | From January 2012 to to follow-up echo (6-12 months following TAVI) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aortic stenosis, Echocardiography, Transcutaneous aortic valve implantation, Left ventricular dysfunction, Left ventricular hypertrophy, Mortality