Heart Valve Prosthesis-Patient Mismatch

This study has been completed.
Sponsor:
Information provided by:
Florence Nightingale Hospital, Istanbul
ClinicalTrials.gov Identifier:
NCT00629902
First received: February 27, 2008
Last updated: May 9, 2008
Last verified: May 2008
  Purpose

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


Condition
Heart Valve Diseases

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Impact of Prosthesis-Patient Mismatch on Clinical Outcomes After Mitral Valve Replacement

Resource links provided by NLM:


Further study details as provided by Florence Nightingale Hospital, Istanbul:

Estimated Enrollment: 100
Study Start Date: February 2008
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
A1
Patients with prosthesis-patient mismatch after mitral valve replacement
A2
Patients without prosthesis mismatch after mitral valve replacement

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Tertiary care clinic

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00629902

Locations
Turkey
T.C. Bilim University, Medical Faculty, Florence Nightingale Hospital, Division of Cardiology
Istanbul, Sisli, Turkey, 34381
Sponsors and Collaborators
Florence Nightingale Hospital, Istanbul
Investigators
Principal Investigator: Saide Aytekin, Professor T.C. Istanbul Bilim University, Medical Faculty, Florence Nightingale Hospital, Division of Cardiology
  More Information

Publications:
Responsible Party: Saide Aytekin, Florence Nightingale Hospital
ClinicalTrials.gov Identifier: NCT00629902     History of Changes
Other Study ID Numbers: AT-1974
Study First Received: February 27, 2008
Last Updated: May 9, 2008
Health Authority: Turkey: Ministry of Health

Keywords provided by Florence Nightingale Hospital, Istanbul:
Heart valve prosthesis

Additional relevant MeSH terms:
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 20, 2014