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A prospective study of 600 patients with severe aortic stenosis (AS) and symptoms who underwent TAVI at the Haukeland university hospital, Bergen, Norway.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Only one arm (intervention=TAVI) | There is not control group/arm for comparison. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biological prosthesis in the aortic valve | Device | Transcatheter aortic valve implantation of bioprosthesis in patients with severe symptomatic aortic stenosis (clinically indicated) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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).
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| Name | Affiliation | Role |
|---|---|---|
| Sahrai Saeed, MD.Ph.D. | Department of Heart Disease Haukeland University Hospital, Begen, Norway | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39920059 | Derived | Wasim D, Ali AM, Bleie O, Packer EJS, Eriksen E, Keilegavlen H, Rajani R, Rotevatn S, Saeed S. Prevalence and predictors of permanent pacemaker implantation in patients with aortic stenosis undergoing transcatheter aortic valve implantation: a prospective cohort study. BMJ Open. 2025 Feb 7;15(2):e093073. doi: 10.1136/bmjopen-2024-093073. | |
| 33472776 |
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There is no plan to make individual participant data available to other researchers
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D006973 | Hypertension |
| D018487 | Ventricular Dysfunction, Left |
| D017379 | Hypertrophy, Left Ventricular |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 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. |
| D014694 |
| Ventricular Outflow Obstruction |
| D014652 | Vascular Diseases |
| D018754 | Ventricular Dysfunction |
| D006332 | Cardiomegaly |
| D006984 | Hypertrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |