Brief Title
Mortality Post-TAVI and Correlation With Haemodynamic Parameters.
Official Title
Mortality Post-TAVI and Correlation With Haemodynamic Parameters.
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 Type
Observational
Primary Outcome
Death post-TAVI
Condition
Aortic Valve Stenosis
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
1200
Start Date
January 1, 2008
Completion Date
December 31, 2017
Primary Completion Date
December 31, 2017
Eligibility Criteria
Inclusion Criteria: - All patients with TAVI within the Royal Brompton & Harefield NHS Foundation Trust Exclusion Criteria: - None
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Thomas Luescher, ,
Administrative Informations
NCT ID
NCT03769545
Organization ID
258843
Responsible Party
Principal Investigator
Study Sponsor
Royal Brompton & Harefield NHS Foundation Trust
Study Sponsor
Thomas Luescher, Study Director, Director of Research Education and Development, Cardiology (RBH)
Verification Date
December 2018