The Impact of Transcatheter Aortic Valve Implantation on Left Ventricular Structure, Function and Outcome in Patients With Aortic Stenosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Stenosis
- Sponsor
- Haukeland University Hospital
- Enrollment
- 600
- Primary Endpoint
- The impact of TAVI on left ventriclar mass and hypertrophy regression
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
The impact of TAVI on left ventriclar mass and hypertrophy regression
Time Frame: From January 2012 to follow-up echo (6-12 months following TAVI)
To assess whether removal of valve stenosis by TAVI leads to regression of left ventricular mass (grams).
The impact of TAVI on left ventricular function recovery
Time Frame: From January 2012 to to follow-up echo (6-12 months following TAVI)
To assess improvement in systolic function (increase in ejection fraction) following TAVI
The impact of TAVI on arterial load (systemic arterial stiffness and arterial compliance).
Time Frame: From January 2012 to to follow-up echo (6-12 months following TAVI)
To assess improvement in echocardiographic arterial stiffness and arterial compliance and global left ventricular load (Zva=valvular-arterial impedance) following TAVI.
The impact of TAVI on all-cause mortality
Time Frame: From January 2012 to Mai 2020 (date for assesment vital status) + prolonged follow-up (up to 10 years)
To assess the long-term survival benefits of TAVI