Transcatheter Aortic Valve Implantation in Western NORway

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04417829

Acronym

TAVI-NOR

Enrollment

600

Registered

2020-06-05

Start date

2012-01-31

Completion date

2019-07-31

Last updated

2023-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Stenosis, Hypertension

Keywords

Aortic stenosis, Echocardiography, Transcutaneous aortic valve implantation, Left ventricular dysfunction, Left ventricular hypertrophy, Mortality

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.

Interventions

DEVICEBiological prosthesis in the aortic valve

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
The impact of TAVI on left ventricular function recovery	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).	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	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
The impact of TAVI on left ventriclar mass and hypertrophy regression	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).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026