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Heart Valve Prosthesis-Patient Mismatch

NCT ID: NCT00629902

Last Updated: 2008-05-12

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

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-05-31

Brief Summary

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The purpose of this study is to determine the frequency of prosthesis-patient mismatch after mitral valve replacement and its effect on clinical outcomes.

Detailed Description

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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.

Conditions

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Heart Valve Diseases

Keywords

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Heart valve prosthesis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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A1

Patients with prosthesis-patient mismatch after mitral valve replacement

No interventions assigned to this group

A2

Patients without prosthesis mismatch after mitral valve replacement

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Florence Nightingale Hospital, Istanbul

OTHER

Sponsor Role lead

Responsible Party

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Florence Nightingale Hospital

Principal Investigators

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Saide Aytekin, Professor

Role: PRINCIPAL_INVESTIGATOR

T.C. Istanbul Bilim University, Medical Faculty, Florence Nightingale Hospital, Division of Cardiology

Locations

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T.C. Bilim University, Medical Faculty, Florence Nightingale Hospital, Division of Cardiology

Istanbul, Sisli, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 17723820 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15808760 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17339554 (View on PubMed)

Other Identifiers

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AT-1974

Identifier Type: -

Identifier Source: org_study_id