Heart Valve Prosthesis-Patient Mismatch
Impact of Prosthesis-Patient Mismatch on Clinical Outcomes After Mitral Valve Replacement
1 other identifier
observational
100
1 country
1
Brief Summary
The purpose of this study is to determine the frequency of prosthesis-patient mismatch after mitral valve replacement and its effect on clinical outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2008
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 27, 2008
CompletedFirst Posted
Study publicly available on registry
March 6, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedMay 12, 2008
May 1, 2008
3 months
February 27, 2008
May 9, 2008
Conditions
Keywords
Study Arms (2)
A1
Patients with prosthesis-patient mismatch after mitral valve replacement
A2
Patients without prosthesis mismatch after mitral valve replacement
Eligibility Criteria
Tertiary care clinic
You may qualify if:
- Patients \> 18 years with a clinical condition of mitral valve prosthesis
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
T.C. Bilim University, Medical Faculty, Florence Nightingale Hospital, Division of Cardiology
Istanbul, Sisli, 34381, Turkey (Türkiye)
Related Publications (3)
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.
PMID: 17723820BACKGROUNDLi 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.
PMID: 15808760BACKGROUNDMagne 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.
PMID: 17339554BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Saide Aytekin, Professor
T.C. Istanbul Bilim University, Medical Faculty, Florence Nightingale Hospital, Division of Cardiology
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 27, 2008
First Posted
March 6, 2008
Study Start
February 1, 2008
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
May 12, 2008
Record last verified: 2008-05