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Enrolling by Invitation

NCT Number: NCT05090540

Transcatheter Versus Standard Surgical Mitral Valve Operation for Secondary Mitral Regurgitation

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.

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Key information

Conditions

Severe Mitral Valve Regurgitation (Disorder) Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Valve Insufficiency

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Cardiologique Du Nord, Saint-Denis, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Mitraclip procedure

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.

Restrictive Mitral Annuloplastie

Procedure

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

Other names: Undersizing Mitral Annuloplastie

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.

Primary outcomes

  1. Left Ventricular Reverse Remodelling

    Time frame: 5 years

    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

Secondary outcomes

  1. Overall Mortality

    Time frame: 5 years

    The secondary endpoint of the study is the evaluation of overall mortality

  2. Cardiac Death

    Time frame: 5 years

    The secondary endpoint of the study is the evaluation of cardiac death

  3. Major Adverse Cardiac or Cerebrovascular Events (MACCE)

    Time frame: 5 years

    Composite of major adverse cardiac or cerebrovascular events (rate of death, stroke, subsequent mitral valve surgery, hospitalization for heart failure, or an increase in New York Heart Association class higher than one), serious adverse events, recurrent mitral regurgitation, quality of life, and rehospitalization.

  4. Echocardiographic Parameter Changes (LVEF)

    Time frame: 5 years

    Changes from baseline parameters including left ventricular ejection fraction

  5. Echocardiographic Parameter Changes (recurrence)

    Time frame: 5 years

    Recurrent moderate-to-severe mitral regurgitation after intervention

  6. Echocardiographic Parameter Changes (LVEDD)

    Time frame: 5 years

    Changes from baseline Left Ventricular End Diastolic Diameter

  7. Echocardiographic Parameter Changes (Mitral Valve tenting area and height)

    Time frame: 5 years

    Changes from baseline tenting area and height

  8. Echocardiographic Parameter Changes (Pulmonary artery systolic pressure)

    Time frame: 5 years

    Changes from baseline pulmonary artery systolic pressure

  9. Echocardiographic Parameter Changes (anteroposterior mitral valve annular diameter)

    Time frame: 5 years

    Changes from baseline anteroposterior mitral valve annular diameter

  10. Echocardiographic Parameter Changes ( interpapillary distance)

    Time frame: 5 years

    Changes from baseline distance between papillary muscles

Sponsors and collaborators

Lead sponsor

Centre Cardiologique du Nord

Other

Collaborators

  • Campus Bio-Medico University
  • Henri Mondor University Hospital
  • Hokkaido University
  • University of Genova

Registry information

Official study title

Transcatheter Edge to Edge Mitral Valve Repair Versus Standard Surgical Mitral Valve Operation for Secondadry Mitral Regurgitation

Acronym: TEERMISO

Important dates

Study start
2017
Primary completion
2024
Study completion
2026
First posted
Oct 22, 2021
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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