NCT04417829

Transcatheter Aortic Valve Implantation in Western NORway

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 600 (actual)
• Sponsor: Haukeland University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Aortic Stenosis
• Hypertension

Interventions

Type	Name	Description
DEVICE	Biological prosthesis in the aortic valve	Transcatheter aortic valve implantation of bioprosthesis in patients with severe symptomatic aortic stenosis (clinically indicated)

Timeline

• Start date: 2012-01-01
• Primary completion: 2019-07-01
• Completion: 2019-07-01
• First posted: 2020-06-05
• Last updated: 2023-09-22