Transcatheter Aortic Valve Implantation in Western NORway

Haukeland University Hospital600 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

600

Conditions

Aortic Stenosis Hypertension

Interventions

Biological prosthesis in the aortic valveDEVICE

Transcatheter aortic valve implantation of bioprosthesis in patients with severe symptomatic aortic stenosis (clinically indicated)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Hemodynamically severe aortic stenosis and symptoms 2. A decision of TAVI by Heart team 3. Patients undergoing TAVI (transcatheter aortic valve implantation) 4. Life expectancy \> 1-2 years Exclusion Criteria: 1. Sever frailty 2. Severly reduced cognitive function 3. Multiple comorbid conditions 4. Technically not suited for TAVI

Outcomes

Primary Outcomes

The impact of TAVI on all-cause mortality

To assess the long-term survival benefits of TAVI

Time frame: 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).

Time frame: 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

Time frame: 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.

Time frame: From January 2012 to to follow-up echo (6-12 months following TAVI)

Data from ClinicalTrials.gov

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