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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON39560
Enrollment
25
Registered
2014-10-16
Start date
2015-02-04
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

mitral valve function mitral valve repair

Interventions

None listed

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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 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

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

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)