Transcatheter Aortic Valve Implantation in Western NORway

Completed

• Conditions: Aortic Stenosis; Hypertension
• Interventions: Device: Biological prosthesis in the aortic valve

• Registration Number: NCT04417829
• Lead Sponsor: Haukeland University Hospital

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.

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2019-07
• Study Completion: 2019-07
• Status Verified: 2020-05
• Study First Submitted: 2020-05-26
• Study First Submitted QC: 2020-06-02
• Study First Posted: 2020-06-05
• Last Update Submitted: 2023-09-21
• Last Update Posted: 2023-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Only one arm (intervention=TAVI)	Biological prosthesis in the aortic valve	There is not control group/arm for comparison.

Primary Outcome Measures

Name	Time	Method
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.
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