Transcatheter Versus Standard Surgical Mitral Valve Operation for Secondary Mitral Regurgitation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-01

Study Completion Date

2025-12-30

Brief Summary

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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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Detailed Description

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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

Conditions

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Severe Mitral Valve Regurgitation (Disorder)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Trancatheter Edge to Edge Repair

Intervention Type 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

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

Mitral Valve Replacement

Intervention Type 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 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.

Restrictive Mitral Annuloplastie

Intervention Type PROCEDURE

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

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

Restrictive Mitral Annuloplastie/Subvalvular Repair

Intervention Type 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.

Interventions

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Trancatheter Edge to Edge Repair

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

Intervention Type DEVICE

Mitral Valve Replacement

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

Intervention Type PROCEDURE

Restrictive Mitral Annuloplastie

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

Intervention Type PROCEDURE

Restrictive Mitral Annuloplastie/Subvalvular Repair

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.

Intervention Type PROCEDURE

Other Intervention Names

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Mitraclip procedure Undersizing Mitral Annuloplastie

Eligibility Criteria

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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%