Mortality Post-TAVI and Correlation With Haemodynamic Parameters.

Completed

• Conditions: Aortic Valve Stenosis

• Registration Number: NCT03769545
• Lead Sponsor: Royal Brompton & Harefield NHS Foundation Trust

Brief Summary

Until a few years ago the only interventional option available for severe aortic stenosis was surgical aortic valve replacement. About a decade ago, a novel percutaneous technique was applied for the first time in humans, the transcatheter aortic valve implantation (TAVI). Initially this procedure was reserved for those patients deemed too high risk for surgical intervention. As technology progressed in this domain, the indication for TAVI expanded to a broader population of patient with severe aortic stenosis. To-date there are no long-term data for mortality and this is the central question this study will explore in correlation with haemodynamic parameters. Essentially, this study will explore the effect of TAVI in the long term. All patients that had a TAVI within the RBH\&HH NHS Foundation Trust between January 2008 and December 2017 will be included in the study. This is a retrospective study.

Detailed Description

Aortic valve stenosis is the most prevalent valvulopathy in the developed world countries. Until a few years ago the only interventional option available for severe aortic stenosis was surgical aortic valve replacement. About a decade ago, a novel percutaneous technique was applied for the first time in humans, the transcatheter aortic valve implantation (TAVI) as a keyhole procedure. Initially this procedure was reserved for those patients deemed too high risk for surgical intervention. As technology progressed in this domain, the indication for TAVI expanded to a broader population of patient with severe aortic stenosis. As the experience broadens there are no long-term data for mortality and this is the central question this study will explore in correlation with haemodynamic parameters. Essentially, this study will explore the effect of TAVI in the long term. All patients that had a TAVI within the RBH\&HH NHS Foundation Trust between January 2008 and December 2017 will be included in the study. This is a retrospective study and will not change anything in the patients' standard of care.

Study Timeline

• Study Start: 2008-01-01
• Primary Completion: 2017-12-31
• Study Completion: 2017-12-31
• Status Verified: 2018-12
• Study First Submitted: 2018-12-05
• Study First Submitted QC: 2018-12-06
• Last Update Submitted: 2018-12-06
• Study First Posted: 2018-12-07
• Last Update Posted: 2018-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

• All patients with TAVI within the Royal Brompton & Harefield NHS Foundation Trust

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Death post-TAVI	Within 3 years from TAVI procedure	Death during or after TAVI