Transcatheter Versus Standard Surgical Mitral Valve Operation for Secondary Mitral Regurgitation

NCT05090540 | Enrolling By Invitation

• 1 other identifier: CN-21-23
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 2

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.

Conditions

Severe Mitral Valve Regurgitation (Disorder)

Keywords

SMR; TEER; MVRpl; MVR; RMA; Subvalvular Repair

Outcome Measures

Primary Outcomes (1)

• Left Ventricular Reverse Remodelling

  The primary end point of the study is the degree of left ventricular reverse remodeling, as assessed by means of the left ventricular end systolic dimension on the basis of transthoracic echocardiography

  5 years

Secondary Outcomes (10)

• Overall Mortality

  5 years

• Cardiac Death

  5 years

• Major Adverse Cardiac or Cerebrovascular Events (MACCE)

  5 years

• Echocardiographic Parameter Changes (LVEF)

  5 years

• Echocardiographic Parameter Changes (recurrence)

  5 years

Study Arms (4)

Transcatheter Edge to Edge Repair

TEER procedure is performed by apposing the edges of the anterior and posterior leaflet (edge-to-edge) of MV. If the use of one MitraClip device does not result in sufficient reduction in mitral regurgitation, a second MitraClip device may be used to reduce MR optimizing the procedure.

Device: Trancatheter Edge to Edge Repair

Mitral Valve Replacement

Mitral-valve replacement includes complete preservation of the subvalvular apparatus to avoid dilation of the left ventricle over time. The technique of preservation, type of prosthetic valve implanted, and technique of suture placement has been chosen according to the preference of the surgeons. In SMR due to ischemic cardiomyopathy, CABG operation(Revascularization) is required

Procedure: Mitral Valve Replacement

Restrictive Mitral Annuloplasty

RMA may be performed with the use of complete rigid or semi-rigid annuloplasty ring which has been downsized for the annulus diameter. Since patients who received RMA have coronary artery lesions, a CABG operation is useful to ensure favorable remodeling of the left ventricle.

Procedure: Restrictive Mitral Annuloplastie

Restrictive Mitral Annuloplastie Plus Subvalvular Repair

RMA may be associated with the use of a subvalvular repair (SVR). The SVR permits the approximation or the relocation of papillary muscles which is displaced by post infarction scar formation. In patients who received SVR due to ischemic cardiomyopathy CABG operation is required

Procedure: Restrictive Mitral Annuloplastie/Subvalvular Repair

Interventions

Trancatheter Edge to Edge Repair DEVICE

TEER is performed by apposing the edges of the anterior and posterior leaflet (edge-to-edge) of prolapsed MV. The patient may be under conscious sedation or general anesthesia, depending on hospital standard practice. The procedure is performed through femoral venous access and the inter-atrial septum is crossed using standard techniques. Trans-septal puncture allows MitraClip Steerable Guide Catheter (Guide) to advance so that the guide is positioned over the mitral valve. The MitraClip delivery catheter is advanced to the MitraClip device and emerges from the tip of the guide into the left atrium. The MitraClip device can now be opened and advanced through the MV in the LV. Once in the LV, it is pulled back to grasp the leaflets. Two-dimensional and/or 3-dimensional echocardiography and color Doppler are useful for evaluating the anatomical features of the mitral valve and directing the procedure until the double orifice is formed alongside evaluating residual mitral regurgitation

Also known as: Mitraclip procedure

Transcatheter Edge to Edge Repair

Mitral Valve Replacement PROCEDURE

Mitral valve replacement is performed using mechanical or biological prosthesis while preserving the subvalvular apparatus to avoid dilation of the left ventricle over time.

Mitral Valve Replacement

Restrictive Mitral Annuloplastie PROCEDURE

Mitral valve repair consists of a restrictive mitral annuloplasty (RMA) using a prosthetic ring

Also known as: Undersizing Mitral Annuloplastie

Restrictive Mitral Annuloplasty

Restrictive Mitral Annuloplastie/Subvalvular Repair PROCEDURE

RMA may be associated with the use of a subvalvular repair (SR). The SR permits the approximation or the relocation of papillary muscles which is displaced by post infarction scar formation.

Restrictive Mitral Annuloplastie Plus Subvalvular Repair

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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%

You may not qualify if:

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

Sponsors & Collaborators

• Centre Cardiologique du Nord: lead
• Campus Bio-Medico University: collaborator
• Henri Mondor University Hospital: collaborator
• Hokkaido University: collaborator
• University of Genova: collaborator

Study Sites (2)

Francesco Nappi

Saint-Denis, 93200, France

Location

Centre Cardiologique Du Nord

Saint-Denis, France

Location

Related Publications (2)

• Nappi F, Singh SSA, Salsano A, Spadaccio C, Shingu Y, Wakasa S, Fiore A. Study protocol for an international registry observational study evaluating clinical outcomes of transcatheter versus standard surgical mitral valve operation for secondary mitral regurgitation: the TEERMISO study. BMJ Open. 2025 Jan 8;15(1):e086888. doi: 10.1136/bmjopen-2024-086888.

  PMID: 39779262 DERIVED

• Nappi F, Avtaar Singh SS, Salsano A, Nassif A, Shingu Y, Wakasa S, Fiore A, Spadaccio C, El-Dean Z. A Protocol Investigation Comparing Transcatheter Repair with the Standard Surgical Procedure for Secondary Mitral Regurgitation. J Clin Med. 2024 Dec 18;13(24):7742. doi: 10.3390/jcm13247742.

  PMID: 39768667 DERIVED

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Francesco Nappi, MD

  Centre Cardiologique du Nord

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: October 22, 2021
• Study Start: June 1, 2017
• Primary Completion: March 1, 2024
• Study Completion: December 30, 2025
• Last Updated: March 5, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)