Transcatheter Aortic Valve Implantation in Western NORway (TAVI-NOR)

Haukeland University Hospital

Status: Completed

Conditions: Hypertension; Aortic Stenosis

Treatments: Device: Biological prosthesis in the aortic valve

Study type: Observational

Funder types: Other

Identifiers

NCT04417829

2019/33814/REK vest

Details and patient eligibility

About

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

Full 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.

Enrollment: 600 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

600 participants in 1 patient group

Only one arm (intervention=TAVI)

Description:

There is not control group/arm for comparison.

Treatment:

Device: Biological prosthesis in the aortic valve