Clinical trial NCT05090540: Transcatheter Versus Standard Surgical Mitral Valve Operation for Secondary Mitral Regurgitation
Official title: Transcatheter Edge to Edge Mitral Valve Repair Versus Standard Surgical Mitral Valve Operation for Secondadry Mitral Regurgitation
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Severe Mitral Valve Regurgitation (Disorder)
Keywords: SMR; TEER; MVRpl; MVR; RMA; Subvalvular Repair
Lead sponsor: Centre Cardiologique du Nord
Sponsor class: OTHER
Collaborators: name: Campus Bio-Medico University
name: Henri Mondor University Hospital
name: Hokkaido University
name: University of Genova
First posted: 2021-10-22
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults with severe secondary mitral regurgitation with or without multivessel coronary artery disease who were symptomatic for congestive heart failure and unresponsive to medical therapy were eligible for surgical repair or replacement combined or not to coronary artery bypass graft (CABG). The severity of SMR was evaluated by transthoracic echocardiography, which was performed using European Society of Echocardiography criteria. Severe MR was defined as an effective regurgitant orifice area (EROA) of at least 0.4 cm2 or by a combination of adjunctive echocardiographic quantification methods according to guidelines. MR grade was defined according to EROA.

Brief summary: The mechanical intervention is treating secondary mitral regurgitation (SMR) which may be performed using the standard open surgical approach or transcatheter edge to edge repair (TEER). The key question of this study is to establish the difference in left ventricular reverse remodeling after adjustment for death, as assessed by means of the left ventricular end-systolic dimension(LVESD), all-cause and cause-specific (cardiac vs noncardiac) mortality in patients who received the TEER vs the standard surgical procedure for SMR.

Detailed description: The target population enrolled in the registry includes patients with moderate to severe secondary mitral regurgitation due to cardiomyopathy of either ischemic or non-ischemic etiology who have had TEER or standard surgical procedure of their mitral valves with or without CABG. Individuals were adequately treated per applicable standards, including for coronary artery disease, LV dysfunction, mitral regurgitation, and heart failure. Patients enrolled in the studies were NYHA functional class II, III, or outpatient NYHA IV.

Four groups of patients are included in the study. Patients who were managed with TEER, patients who received mitral valve replacement and recipients of mitral valve repair who underwent surgery with the use of restrictive annuloplasty alone or combined with subvalvular repair. Four groups of patients are included in the study. Patients who were managed with TEER, patients who received mitral valve replacement, and those who received mitral valve repair who underwent surgery with the use of restrictive annuloplasty alone or combined with subvalvular repair

Eligibility criteria: Inclusion Criteria:

* Adult
* Ischemic NoIschemic cardiomyopathy
* EROA\> 0,2 cm2 or Regurgitant Volume \> 30 ml (ESC guidelines).
* EROA ≥ 0.4 cm2 with tethering (ACC/AHA)
* MR Grade 3/4
* Eligible for TEE, surgical repair and replacement of mitral valve
* Coronary artery disease with or without the need for coronary revascularization
* Average value LVEDD 62 mm LVEF 42%

Exclusion Criteria:

* Pediatric
* Any echocardiographic evidence of structural (chordal or leaflet) mitral-valve disease
* ruptured papillary

Primary outcomes:
measure: Left Ventricular Reverse Remodelling
timeFrame: 5 years
Secondary outcomes:
measure: Overall Mortality
timeFrame: 5 years
measure: Cardiac Death
timeFrame: 5 years
measure: Major Adverse Cardiac or Cerebrovascular Events (MACCE)
timeFrame: 5 years
measure: Echocardiographic Parameter Changes (LVEF)
timeFrame: 5 years
measure: Echocardiographic Parameter Changes (recurrence)
timeFrame: 5 years
measure: Echocardiographic Parameter Changes (LVEDD)
timeFrame: 5 years
measure: Echocardiographic Parameter Changes (Mitral Valve tenting area and height)
timeFrame: 5 years
measure: Echocardiographic Parameter Changes (Pulmonary artery systolic pressure)
timeFrame: 5 years
measure: Echocardiographic Parameter Changes (anteroposterior mitral valve annular diameter)
timeFrame: 5 years
measure: Echocardiographic Parameter Changes ( interpapillary distance)
timeFrame: 5 years
Other outcomes:
Locations:
city: Saint Denis
country: France
facility: Francesco Nappi
city: Saint Denis
country: France
facility: Centre Cardiologique Du Nord
Study officials:
affiliation: Centre Cardiologique du Nord
name: Francesco Nappi, MD
role: PRINCIPAL_INVESTIGATOR
References: