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Mortality Post-TAVI and Correlation With Haemodynamic Parameters.

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ClinicalTrials.gov Identifier: NCT03769545
Recruitment Status : Completed
First Posted : December 7, 2018
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Panagiotis Savvoulidis, 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.

Condition or disease
Aortic Valve Stenosis

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.

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Study Type : Observational
Actual Enrollment : 1200 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Mortality Post-TAVI and Correlation With Haemodynamic Parameters.
Actual Study Start Date : January 1, 2008
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Death post-TAVI [ Time Frame: Within 3 years from TAVI procedure ]
    Death during or after TAVI



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with TAVI within the Royal Brompton & Harefield NHS Foundation Trust
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03769545


Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
Investigators
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Study Director: Thomas Luescher Director of Research Education and Development, Cardiology (RBH)

Publications:
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Responsible Party: Panagiotis Savvoulidis, Clinical Fellow in Interventional Cardiology, Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03769545     History of Changes
Other Study ID Numbers: 258843
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction