NCT03389542 Early Mitral ValvE Repair Versus Watchful Waiting for Asymptomatic SEvere Degenerative Mitral Regurgitation
| NCT ID | NCT03389542 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire, Amiens |
| Condition | Degenerative Mitral Regurgitation (MR) Due to Leaflet Prolapse |
| Study Type | INTERVENTIONAL |
| Enrollment | 424 participants |
| Start Date | 2018-04-10 |
| Primary Completion | 2033-04-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 424 participants in total. It began in 2018-04-10 with a primary completion date of 2033-04-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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. In this group of patients, differing views of the risks of uncorrected severe MR exist: considered as benign by those supporting medical "watchful waiting" or associated with significant excess mortality/morbidity by those advocating early surgery. This controversy can only be resolved by a randomized controlled trial which is still lacking. The main objective is to demonstrate the superiority of early mitral valve repair in patients with asymptomatic severe MR due to leaflet prolapse compared to an initial conservative management in terms of all-cause death and cardiovascular morbidity during five years follow-up.
Eligibility Criteria
Inclusion 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% Exclusion Criteria: * 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
Contact & Investigator
Christophe TRIBOUILLOY, MD, PhD
PRINCIPAL INVESTIGATOR
CHU Amiens
Frequently Asked Questions
Who can join the NCT03389542 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Degenerative Mitral Regurgitation (MR) Due to Leaflet Prolapse. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03389542 currently recruiting?
Yes, NCT03389542 is actively recruiting participants. Contact the research team at tribouilloy.christophe@chu-amiens.fr for enrollment information.
Where is the NCT03389542 trial being conducted?
This trial is being conducted at Amiens, France, Saint-Denis, France.
Who is sponsoring the NCT03389542 clinical trial?
NCT03389542 is sponsored by Centre Hospitalier Universitaire, Amiens. The principal investigator is Christophe TRIBOUILLOY, MD, PhD at CHU Amiens. The trial plans to enroll 424 participants.