- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00629902
Heart Valve Prosthesis-Patient Mismatch
May 9, 2008 updated by: Florence Nightingale Hospital, Istanbul
Impact of Prosthesis-Patient Mismatch on Clinical Outcomes After Mitral Valve Replacement
The purpose of this study is to determine the frequency of prosthesis-patient mismatch after mitral valve replacement and its effect on clinical outcomes.
Study Overview
Status
Completed
Conditions
Detailed Description
Mitral valve replacement (MVR) is associated with higher short and long term mortality than aortic valve replacement or mitral valve repair.
The suboptimal results of MVR underline the importance of identifying and preventing prosthesis- patient mismatch.
The effective orifice area (EOA) of prosthetic valves used for MVR is often too small in relation to body size, thus causing a mismatch between valve EOA and transvalvular flow.
As a consequence, normally functioning mitral prostheses often have relatively high gradients that are similar to those found in patients with mild to moderate mitral stenosis.
Residual pressure gradients across mitral prostheses delay the regression of left atrial and pulmonary arterial hypertension.
Pulmonary hypertension may cause rightsided failure and is an important risk factor for morbidity and mortality in patients with cardiovascular diseases.
However data about the frequency of prosthesis-patient mismatch after mitral valve replacement and its effect on clinical outcome is inconclusive.
Predetermined outcomes will be evaluated in the clinical course of this condition.
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Sisli
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Istanbul, Sisli, Turkey, 34381
- T.C. Bilim University, Medical Faculty, Florence Nightingale Hospital, Division of Cardiology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Tertiary care clinic
Description
Inclusion Criteria:
- Patients > 18 years with a clinical condition of mitral valve prosthesis
Exclusion Criteria:
- Evidence of prosthesis valve dysfunction (dehisence, endocarditis or thrombus of prosthetic mitral valve)
- Concomitant aortic valve prosthesis and tricuspid valve prosthesis
- Presence of > +2 aortic valve regurgitation and/or mild aortic stenosis
- Prosthetic mitral valve replacement operation < 6 months
- Left ventricular ejection fraction < 50%
- Chronic obstructive pulmonary disease
- Concomitant hypertrophic cardiomyopathy, atrial septal defect
- Patients with poor ehocardiographic window
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
A1
Patients with prosthesis-patient mismatch after mitral valve replacement
|
A2
Patients without prosthesis mismatch after mitral valve replacement
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Saide Aytekin, Professor, T.C. Istanbul Bilim University, Medical Faculty, Florence Nightingale Hospital, Division of Cardiology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Totaro P, Argano V. Patient-prosthesis mismatch after mitral valve replacement: myth or reality? J Thorac Cardiovasc Surg. 2007 Sep;134(3):697-701. doi: 10.1016/j.jtcvs.2007.04.031.
- Li M, Dumesnil JG, Mathieu P, Pibarot P. Impact of valve prosthesis-patient mismatch on pulmonary arterial pressure after mitral valve replacement. J Am Coll Cardiol. 2005 Apr 5;45(7):1034-40. doi: 10.1016/j.jacc.2004.10.073.
- Magne J, Mathieu P, Dumesnil JG, Tanne D, Dagenais F, Doyle D, Pibarot P. Impact of prosthesis-patient mismatch on survival after mitral valve replacement. Circulation. 2007 Mar 20;115(11):1417-25. doi: 10.1161/CIRCULATIONAHA.106.631549. Epub 2007 Mar 5.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2008
Primary Completion (Actual)
May 1, 2008
Study Completion (Actual)
May 1, 2008
Study Registration Dates
First Submitted
February 27, 2008
First Submitted That Met QC Criteria
March 5, 2008
First Posted (Estimate)
March 6, 2008
Study Record Updates
Last Update Posted (Estimate)
May 12, 2008
Last Update Submitted That Met QC Criteria
May 9, 2008
Last Verified
May 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AT-1974
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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