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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
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Study Description
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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.

Condition or disease
Aortic Valve Stenosis

Study Design
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Study Type : Observational
Estimated Enrollment : 6 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Determination of the Acute Effects of Aortic Stenosis on Coronary Artery Haemodynamics
Study Start Date : December 2009
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
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Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Biospecimen Retention:   Samples With DNA
Myocardial biopsy specimens

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): 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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01118442     History of Changes
Other Study ID Numbers: 1424
First Posted: May 6, 2010    Key Record Dates
Last Update Posted: February 8, 2017
Last Verified: February 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