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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04417829
Other study ID # 2019/33814/REK vest
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


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)
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