Clinical trial NCT04417829: Transcatheter Aortic Valve Implantation in Western NORway
Official title: The Impact of Transcatheter Aortic Valve Implantation on Left Ventricular Structure, Function and Outcome in Patients With Aortic Stenosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Stenosis
Hypertension
Keywords: Aortic stenosis
Echocardiography
Transcutaneous aortic valve implantation
Left ventricular dysfunction
Left ventricular hypertrophy
Mortality
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2020-06-05
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 600 patients with moderate or severe aortic stenosis of any etiology, and symptoms, where aortic valve intervention was clinially indicated. All patients underwent a successful TAVI (transcatheter aortic valve implantation).

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.

Eligibility criteria: 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

Primary outcomes:
measure: The impact of TAVI on all-cause mortality
timeFrame: From January 2012 to Mai 2020 (date for assesment vital status) + prolonged follow-up (up to 10 years)
measure: The impact of TAVI on left ventriclar mass and hypertrophy regression
timeFrame: From January 2012 to follow-up echo (6-12 months following TAVI)
measure: The impact of TAVI on left ventricular function recovery
timeFrame: From January 2012 to to follow-up echo (6-12 months following TAVI)
measure: The impact of TAVI on arterial load (systemic arterial stiffness and arterial compliance).
timeFrame: From January 2012 to to follow-up echo (6-12 months following TAVI)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Heart Disease Haukeland University Hospital, Begen, Norway
name: Sahrai Saeed, MD.Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mohamed Ali A, Wasim D, Loland KH, Rotevatn S, Bleie O, Saeed S. Impact of transcatheter aortic valve implantation on left ventricular function recovery, mass regression and outcome in patients with aortic stenosis: protocol of the TAVI-NOR prospective study. BMJ Open. 2021 Jan 20;11(1):e039961. doi: 10.1136/bmjopen-2020-039961.