TAVI-NOR: Transcatheter Aortic Valve Implantation in Western NORway

Sponsor

Haukeland University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04417829

Collaborator

(none)

600

Enrollment

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Stenosis Hypertension	Device: Biological prosthesis in the aortic valve

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.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

600 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Jul 1, 2019

Actual Study Completion Date :

Jul 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Only one arm (intervention=TAVI) There is not control group/arm for comparison.	Device: Biological prosthesis in the aortic valve Transcatheter aortic valve implantation of bioprosthesis in patients with severe symptomatic aortic stenosis (clinically indicated)

Arm

Intervention/Treatment

Only one arm (intervention=TAVI)

There is not control group/arm for comparison.

Device: Biological prosthesis in the aortic valve

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

Outcome Measures

Primary Outcome Measures

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).
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.