Transcatheter Aortic Valve Implantation in Western NORway

Hypertension Clinical Trial

— TAVI-NOR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04417829
• Other study ID #: 2019/33814/REK vest
• Status: Completed
• Start date: January 2012
• Est. completion date: July 2019

Study information

• Verified date: May 2020
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: July 2019
• Est. primary completion date: July 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Constriction, Pathologic
• Hypertension

Intervention

Device:
• Biological prosthesis in the aortic valve
Transcatheter aortic valve implantation of bioprosthesis in patients with severe symptomatic aortic stenosis (clinically indicated)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Haukeland University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The impact of TAVI on all-cause mortality	To assess the long-term survival benefits of TAVI	From January 2012 to Mai 2020 (date for assesment vital status) + prolonged follow-up (up to 10 years)
Primary	The impact of TAVI on left ventriclar mass and hypertrophy regression	To assess whether removal of valve stenosis by TAVI leads to regression of left ventricular mass (grams).	From January 2012 to follow-up echo (6-12 months following TAVI)
Primary	The impact of TAVI on left ventricular function recovery	To assess improvement in systolic function (increase in ejection fraction) following TAVI	From January 2012 to to follow-up echo (6-12 months following TAVI)
Primary	The impact of TAVI on arterial load (systemic arterial stiffness and arterial compliance).	To assess improvement in echocardiographic arterial stiffness and arterial compliance and global left ventricular load (Zva=valvular-arterial impedance) following TAVI.	From January 2012 to to follow-up echo (6-12 months following TAVI)