Heart Valve Prosthesis-Patient Mismatch

Completed

• Conditions: Heart Valve Diseases

• Registration Number: NCT00629902
• Lead Sponsor: Florence Nightingale Hospital, Istanbul

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.

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 Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-27
• Study First Submitted QC: 2008-03-05
• Study First Posted: 2008-03-06
• Status Verified: 2008-05
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Last Update Submitted: 2008-05-09
• Last Update Posted: 2008-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

T.C. Bilim University, Medical Faculty, Florence Nightingale Hospital, Division of Cardiology; 🇹🇷 Istanbul, Sisli, Turkey