Determination of the Acute Effects of Aortic Stenosis on Coronary Artery Haemodynamics
February 6, 2017 updated by: Imperial College London
Narrowing of the main valve which controls blood leaving the heart leads to a marked increase in death.
To overcome this narrowing the heart muscle thickens abnormally and contracts more vigorously.
However, in doing so, blood flow patterns to the heart muscle change through mechanisms which are incompletely understood.
New technology allows such heart valve blockages to be fixed using balloons and metal stents inserted through tubes placed in arteries in the leg.
Using sensors placed in these tubes it is possible to make detailed measurements of coronary flow and pressure, and apply new mathematical techniques to allow a better understanding of the detrimental effects that aortic stenosis has on coronary flow, before and after valve surgery.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
6
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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London, United Kingdom
- Recruiting
- Imperial College NHS Trust
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Principal Investigator:
- Justin E Davies, MRCP, PhD
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Sub-Investigator:
- Sayan Sen, MRCP
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients undergoing transcutaneous aortic valve insertion who meet study criteria
Description
Inclusion Criteria:
- Severe Aortic Stenosis undergoing TAVI
- Normal coronary arteries
- Normal left ventricular function
- No other valvular pathology
Exclusion Criteria:
- Unable to consent
- Left ventricular impairment
- Left ventricular regional wall motion abnormality
- Other valve abnormality
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2009
Primary Completion (Anticipated)
December 1, 2019
Study Completion (Anticipated)
December 1, 2019
Study Registration Dates
First Submitted
May 5, 2010
First Submitted That Met QC Criteria
May 5, 2010
First Posted (Estimate)
May 6, 2010
Study Record Updates
Last Update Posted (Estimate)
February 8, 2017
Last Update Submitted That Met QC Criteria
February 6, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1424
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Aortic Valve Stenosis
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Anteris Technologies Ltd.Active, not recruitingAortic Stenosis | Aortic Valve Calcification | Severe Aortic Valve Stenosis | Symptomatic Aortic StenosisUnited States
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The Medicines CompanyCompletedTranscatheter Aortic Valve Replacement | Aortic Valve Replacement | Severe Aortic StenosisNetherlands, Germany, United Kingdom, Canada, France, Italy, Switzerland
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Anteris Technologies Ltd.Active, not recruitingAortic Valve Calcification | Severe Aortic Valve Stenosis | Symptomatic Aortic StenosisGeorgia
-
Ningbo Jenscare Biotechnology Co., Ltd.UnknownAortic Regurgitation | Severe Aortic Stenosis
-
Edwards LifesciencesCompletedAortic Valve Stenosis | Aortic Valve Stenosis With Insufficiency | Regurgitation, Aortic Valve | Aortic Valve IncompetenceUnited States
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Sorin Group USA, Inc.TerminatedAortic Valve Stenosis | Aortic Valve Stenosis With Insufficiency | Regurgitation, Aortic Valve | Aortic Valve IncompetenceUnited States
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Edwards LifesciencesActive, not recruitingAortic Stenosis | Aortic Regurgitation | Symptomatic Aortic StenosisChina
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BC Centre for Improved Cardiovascular HealthEdwards LifesciencesUnknownTranscatheter Aortic Valve Implantation | Severe Aortic StenosisCanada
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Genesis Medtech CorporationRecruitingDiseases of Aortic Valve | Aortic Stenosis DiseaseChina
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Hospices Civils de LyonRecruiting