Brief Title
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
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.
Study Type
Observational [Patient Registry]
Primary Outcome
The impact of TAVI on all-cause mortality
Condition
Aortic Stenosis
Intervention
Biological prosthesis in the aortic valve
Study Arms / Comparison Groups
Only one arm (intervention=TAVI)
Description: There is not control group/arm for comparison.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
600
Start Date
January 2012
Completion Date
July 2019
Primary Completion Date
July 2019
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
Gender
All
Ages
N/A - N/A
Contacts
Sahrai Saeed, MD.Ph.D., ,
Administrative Informations
NCT ID
NCT04417829
Organization ID
2019/33814/REK vest
Responsible Party
Sponsor
Study Sponsor
Haukeland University Hospital
Study Sponsor
Sahrai Saeed, MD.Ph.D., Principal Investigator, Department of Heart Disease Haukeland University Hospital, Begen, Norway
Verification Date
May 2020