Transcatheter Aortic Valve Implantation… | Clinical Trial

Key information

Conditions

Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiomegaly Cardiovascular Diseases Heart Diseases Heart Valve Diseases Hypertension Hypertrophy Hypertrophy, Left Ventricular Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Vascular Diseases Ventricular Dysfunction Ventricular Dysfunction, Left Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biological prosthesis in the aortic valve

Device

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

Primary outcomes

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
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.

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Registry information

Official study title

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

Acronym: TAVI-NOR

Important dates

Study start: 2012
Primary completion: 2019
Study completion: 2019
First posted: Jun 5, 2020
Registry last updated: Sep 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed