SEP-study: The assessment of normal values in Stress Echocardiographic Parameters in patients after successful mitral valve repair for organic mitral valve regurgitatio

Completed

Conditions: mitral valve function
mitral valve repair
10046973

Registration Number: NL-OMON39560

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 25

Inclusion Criteria

- Age >=18 years;
- Male or female from all ethnicities;
- At least 6 months post successful, isolated MV repair. Successful MV repair: when
there is no or grade 1+ residual or recurrent MV regurgitation, MG <10 mmHg and
MVA >1.5 cm2 after MV surgery and during follow-up. Isolated MV surgery may
include a coronary artery bypass graft (CABG);
- No symptoms (asymptomatic). Symptoms are defined as subjective limitations of
exercise capacity or complaints expressed by the patient and confirmed by the
treating cardiologist;

Exclusion Criteria

- Pulmonary hypertension >50 mmHg at rest;
- Atrial fibrillation (AF) at time of study related stress echo testing;
- Known contraindication or incapability to perform peak exercise or inability to
perform physical stress testing;
- LVEF <45%;
- NYHA class II and more;
- Other heart valve disease of more than mild severity;
- Concomitant surgery during MV repair, e.g. MAZE, TVP procedure;
- Heart valve surgery prior to MV repair;
- Congenital heart disease;
- Disabling comorbidity, e.g. chronic obstructive pulmonary disease (COPD);
- Unable to provide informed consent.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To determine normal values in stress echocardiographic parameters in<br /><br>asymptomatic patients at least 6 months after successful MV repair, including<br /><br>but not limited to the following 2D stress echo parameters: mean gradient (MG)<br /><br>and peak gradient over the repaired MV, systolic pulmonary artery values<br /><br>(sPAP), left ventricular end diastolic dimensions (LVEDD), left ventricular end<br /><br>systolic dimensions (LVEDS), left atrium (LA) dimensions, ejection fraction<br /><br>(EF), mitral valve area (MVA) and severity of MV regurgitation (grade 1-4). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objective is to compare 2D echocardiographic parameters during<br /><br>physical exercise to 3D stress echo parameters (including but not limited to<br /><br>the following 2D and 3D stress echo parameters: mean gradient (MG) and peak<br /><br>gradient over the repaired MV, systolic pulmonary artery values (sPAP), left<br /><br>ventricular end diastolic dimensions (LVEDD), left ventricular end systolic<br /><br>dimensions (LVEDS), left atrium (LA) dimensions, ejection fraction (EF), mitral<br /><br>valve area (MVA) and severity of MV regurgitation (grade 1-4)).</p><br>