Heart Valve Prosthesis-Patient Mismatch

Heart Valve Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00629902
• Other study ID #: AT-1974
• Status: Completed
• Phase: N/A
• First received: February 27, 2008
• Last updated: May 9, 2008
• Start date: February 2008
• Est. completion date: May 2008

Study information

• Verified date: May 2008
• Source: Florence Nightingale Hospital, Istanbul
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Valve Diseases

Locations

Country	Name	City	State
Turkey	T.C. Bilim University, Medical Faculty, Florence Nightingale Hospital, Division of Cardiology	Istanbul	Sisli

Sponsors (1)

Lead Sponsor	Collaborator
Florence Nightingale Hospital, Istanbul

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

Magne J, Mathieu P, Dumesnil JG, Tanné 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. Epub 2007 Mar 5. — View Citation

Totaro P, Argano V. Patient-prosthesis mismatch after mitral valve replacement: myth or reality? J Thorac Cardiovasc Surg. 2007 Sep;134(3):697-701. — View Citation