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

NCT ID: NCT01118442

Last Updated: 2017-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Aortic Valve Stenosis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Justin E Davies, MRCP PhD

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

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Imperial College NHS Trust

London, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Justin E Davies, MRCP, PhD

Role: CONTACT

020 7594 33 86

Sayan Sen, MRCP

Role: CONTACT

020 7594 33 86

Facility Contacts

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Justin E Davies, MRCP, PhD

Role: primary

020 7594 33 86

Sayan Sen, MRCP

Role: backup

020 7594 33 86

References

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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.

Reference Type DERIVED
PMID: 21911781 (View on PubMed)

Other Identifiers

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1424

Identifier Type: -

Identifier Source: org_study_id

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