Early Mitral ValvE Repair Versus Watchful Waiting for Asymptomatic SEvere Degenerative Mitral Regurgitation

NCT ID: NCT03389542

Last Updated: 2018-06-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 424 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-10
• Study Completion Date: 2026-01-01

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.

Detailed Description

Experimental group: In patients randomized to early mitral valve repair, surgery will be performed within 3 months after randomization. Clinical interview will be performed at discharge, at 6 months and afterwards yearly until the end of follow-up. Echocardiography will be performed at discharge, at 6 months and at the end of follow-up.

Control group: Patients randomized to initial conservative management will be followed up by clinical interview and echocardiography every 6 months. Patients will be instructed to report any change in functional status in a prompt manner. Surgery will be indicated at the onset of symptoms or if one or more of the following occur during follow-up: LV end-systolic diameter >40mm, LV ejection fraction <60%, recurrent atrial fibrillation, or resting systolic pulmonary artery pressure >50mmHg.

Conditions

Degenerative Mitral Regurgitation (MR) Due to Leaflet Prolapse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Early mitral valve repair

Surgery will be performed within 3 months after randomization. Clinical interview will be performed at discharge, at 6 months and afterwards yearly until the end of follow-up. Echocardiography will be performed at discharge, at 6 months and at the end of follow-up.

Group Type: EXPERIMENTAL

Surgery

Intervention Type: PROCEDURE

Early mitral valve repair

Conservative management

Patients will be followed up by clinical interview and echocardiography every 6 months.

Group Type: ACTIVE_COMPARATOR

Clinical interview and echocardiography

Intervention Type: OTHER

Clinical interview and echocardiography every 6 months.

Interventions

Surgery

Early mitral valve repair

Intervention Type: PROCEDURE

Clinical interview and echocardiography

Clinical interview and echocardiography every 6 months.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christophe TRIBOUILLOY, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Locations

CHU Amiens-Picardie

Amiens, , France

Site Status: RECRUITING

Centre Cardiologique du Nord

Saint-Denis, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Christophe TRIBOUILLOY, MD, phD

Role: CONTACT

tribouilloy.christophe@chu-amiens.fr

322 087 250 ext. 0033

Facility Contacts

Thomas GOISSEN

Role: primary

thomas.goissen@gmail.com

01 49 33 41 38 ext. 0033

Other Identifiers

2017-A00364-49

Identifier Type: REGISTRY

Identifier Source: secondary_id

PI2017_843_0005

Identifier Type: -

Identifier Source: org_study_id