Transcatheter Aortic Valve Implantation in Western NORway (TAVI-NOR)

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

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

Study Overview

• Status: Completed
• Conditions: Hypertension; Aortic Stenosis
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 600

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Investigators: Principal Investigator: Sahrai Saeed, MD.Ph.D., Department of Heart Disease Haukeland University Hospital, Begen, Norway

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2012
• Primary Completion (Actual): July 1, 2019
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: May 26, 2020
• First Submitted That Met QC Criteria: June 2, 2020
• First Posted (Actual): June 5, 2020

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Mortality; Echocardiography; Left ventricular dysfunction; Aortic stenosis; Left ventricular hypertrophy; Transcutaneous aortic valve implantation
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: 2019/33814/REK vest

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make individual participant data available to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No