NCT00629902

Heart Valve Prosthesis-Patient Mismatch

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Florence Nightingale Hospital, Istanbul · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Valve Diseases

Timeline

• Start date: 2008-02-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2008-03-06
• Last updated: 2008-05-12

Locations

1 site across 1 country: Turkey (Türkiye)