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Determination of the Acute Effects of Aortic Stenosis on Coronary Artery Haemodynamics

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ClinicalTrials.gov Identifier: NCT01118442
Recruitment Status : Recruiting
First Posted : May 6, 2010
Last Update Posted : February 8, 2017
Information provided by (Responsible Party):

May 5, 2010
May 6, 2010
February 8, 2017
December 2009
December 2019   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01118442 on ClinicalTrials.gov Archive Site
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Determination of the Acute Effects of Aortic Stenosis on Coronary Artery Haemodynamics
Determination of the Acute Effects of Aortic Stenosis on Coronary Artery Haemodynamics
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.
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Observational Model: Other
Time Perspective: Prospective
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Retention:   Samples With DNA
Myocardial biopsy specimens
Non-Probability Sample
Patients undergoing transcutaneous aortic valve insertion who meet study criteria
Aortic Valve Stenosis
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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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
December 2019
December 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact: Justin E Davies, MRCP, PhD 020 7594 33 86 justin.davies@imperial.ac.uk
Contact: Sayan Sen, MRCP 020 7594 33 86 sayan.sen@imperial.ac.uk
United Kingdom
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Imperial College London
Imperial College London
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Principal Investigator: Justin E Davies, MRCP PhD Imperial College London
Imperial College London
February 2017