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OpenTrials
Completed

NCT Number: NCT00629902

Heart Valve Prosthesis-Patient Mismatch

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Istanbul, Sisli, 34381, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

Florence Nightingale Hospital, Istanbul

Other

Registry information

Official study title

Impact of Prosthesis-Patient Mismatch on Clinical Outcomes After Mitral Valve Replacement

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Mar 6, 2008
Registry last updated
May 12, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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