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

This study is currently recruiting participants. (see Contacts and Locations)

Verified February 2017 by Imperial College London

Sponsor:

Information provided by (Responsible Party):

Imperial College London

ClinicalTrials.gov Identifier:

NCT01118442

First received: May 5, 2010

Last updated: February 6, 2017

Last verified: February 2017

History of Changes

Purpose

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.

Condition
Aortic Valve Stenosis


Study Type:	Observational
Study Design:	Observational Model: Other Time Perspective: Prospective
Official Title:	Determination of the Acute Effects of Aortic Stenosis on Coronary Artery Haemodynamics

Resource links provided by NLM:

Genetics Home Reference related topics: supravalvular aortic stenosis

Genetic and Rare Diseases Information Center resources: Aortic Valve Stenosis

U.S. FDA Resources

Further study details as provided by Imperial College London:

Biospecimen Retention: Samples With DNA

Myocardial biopsy specimens


Estimated Enrollment:	6
Study Start Date:	December 2009
Estimated Study Completion Date:	December 2019
Estimated Primary Completion Date:	December 2019 (Final data collection date for primary outcome measure)

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients undergoing transcutaneous aortic valve insertion who meet study criteria

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01118442

Contacts


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

Locations


United Kingdom
Imperial College NHS Trust	Recruiting
London, United Kingdom
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
Principal Investigator: Justin E Davies, MRCP, PhD
Sub-Investigator: Sayan Sen, MRCP

Sponsors and Collaborators

Imperial College London

Investigators


Principal Investigator:	Justin E Davies, MRCP PhD	Imperial College London

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Imperial College London
ClinicalTrials.gov Identifier:	NCT01118442 History of Changes
Other Study ID Numbers:	1424
Study First Received:	May 5, 2010
Last Updated:	February 6, 2017

Keywords provided by Imperial College London:


Aortic Stenosis Coronary Flow Wave Intensity Analysis

Additional relevant MeSH terms:


Constriction, Pathologic Aortic Valve Stenosis Pathological Conditions, Anatomical Heart Valve Diseases	Heart Diseases Cardiovascular Diseases Ventricular Outflow Obstruction

ClinicalTrials.gov processed this record on May 22, 2017

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