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Compares treatment options for Degenerative Mitral Regurgitation (MR) Due to Leaflet Prolapse
Official title Early Mitral ValvE Repair Versus Watchful Waiting for Asymptomatic SEvere Degenerative Mitral Regurgitation
ClinicalTrials.gov ID: NCT03389542
What this study is testing
- What it's testing
- Degenerative mitral regurgitation (MR) due to leaflet prolapse is frequent and can be surgically repaired in the vast majority of patients. Despite the efficacy of mitral valve repair, an ongoing international controversy exists regarding the need to perform early surgery in asymptomatic patients with severe MR and no sign of LV dysfunction in whom the probability of successful and durable repair is very high.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Asymptomatic patients according history or an exercise test in those able to perform it if there is a doubt about the absence of symptoms
- Severe (grade IV) degenerative MR due to leaflet prolapse assessed by echocardiography
- LV ejection fraction by Simpson biplane method ≥60% and LV end-systolic diameter by TM echocardiography ≤40mm
- Sinus rhythm on the inclusion ECG
- Pulmonary artery pressure ≤50 mmHg by Doppler echocardiography.
You likely can't join if
- Mitral stenosis or \> mild aortic valve disease (stenosis or regurgitation)
- Congenital heart disease (except patent foramen ovale or atrial septal defect)
- Patients with cardiac prostheses
- Previous myocardial infarction
- Previous cardiac surgery
- Extra cardiac comorbidity with life expectancy \< 5 years
See the full eligibility criteria
- Asymptomatic patients according history or an exercise test in those able to perform it if there is a doubt about the absence of symptoms
- Severe (grade IV) degenerative MR due to leaflet prolapse assessed by echocardiography
- LV ejection fraction by Simpson biplane method ≥60% and LV end-systolic diameter by TM echocardiography ≤40mm
- Sinus rhythm on the inclusion ECG
- Pulmonary artery pressure ≤50 mmHg by Doppler echocardiography.
- High probability of mitral valve repair
- EuroSCORE II ≤ 3%
- Mitral stenosis or \> mild aortic valve disease (stenosis or regurgitation)
- Congenital heart disease (except patent foramen ovale or atrial septal defect)
- Patients with cardiac prostheses
- Previous myocardial infarction
- Previous cardiac surgery
- Extra cardiac comorbidity with life expectancy \< 5 years
- Recent history of psychiatric disease (including drug or alcohol abuse)
- Therapy with an investigational intervention at the time of screening or plan to enrol patient in additional intervention study during participation in this trial
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
- Saint-Denis, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France; Saint-Denis, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.