Determination of the Acute Effects of Aortic Stenosis on Coronary Artery Haemodynamics
1 other identifier
observational
6
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2009
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 5, 2010
CompletedFirst Posted
Study publicly available on registry
May 6, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedFebruary 8, 2017
February 1, 2017
10 years
May 5, 2010
February 6, 2017
Conditions
Keywords
Eligibility Criteria
Patients undergoing transcutaneous aortic valve insertion who meet study criteria
You may qualify if:
- Severe Aortic Stenosis undergoing TAVI
- Normal coronary arteries
- Normal left ventricular function
- No other valvular pathology
You may not qualify if:
- Unable to consent
- Left ventricular impairment
- Left ventricular regional wall motion abnormality
- Other valve abnormality
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Imperial College NHS Trust
London, United Kingdom
Related Publications (1)
Davies JE, Sen S, Broyd C, Hadjiloizou N, Baksi J, Francis DP, Foale RA, Parker KH, Hughes AD, Chukwuemeka A, Casula R, Malik IS, Mikhail GW, Mayet J. Arterial pulse wave dynamics after percutaneous aortic valve replacement: fall in coronary diastolic suction with increasing heart rate as a basis for angina symptoms in aortic stenosis. Circulation. 2011 Oct 4;124(14):1565-72. doi: 10.1161/CIRCULATIONAHA.110.011916. Epub 2011 Sep 12.
PMID: 21911781DERIVED
Biospecimen
Myocardial biopsy specimens
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Justin E Davies, MRCP PhD
Imperial College London
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2010
First Posted
May 6, 2010
Study Start
December 1, 2009
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
February 8, 2017
Record last verified: 2017-02