Change in LVEF Following Transcatheter Mitral Edge-To-Edge Repair (MITRA-EF)

March 28, 2022 updated by: Rabin Medical Center

MITRA-EF: A Multi-Center Registry Evaluating Left Ventricular Function in Patients Undergoing Transcatheter Mitral Edge-To-Edge Repair

Little is known regarding the impact of transcatheter mitral valve edge-to-edge repair (TEER) on the acute changes in left ventricular ejection fraction (LVEF) and the effect of an acute reduction in LVEF, the so-called "afterload mismatch" (AM), on prognosis.

We thereby aim to assess changes in LVEF after TEER, identify rate and predictors AM, and estimate its impact on prognosis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Following surgical mitral valve repair for primary mitral regurgitation (MR), improved left ventricular (LV) and left atrial remodeling was demonstrated. However, little is known regarding the impact of percutaneous mitral edge-to-edge repair in patients with secondary MR or those with primary MR who are not candidates for surgery. Studies in these populations are limited, vary in the inclusion criteria and the etiology of mitral regurgitation. Some show no improvement in LV ejection function (LVEF) following percutaneous repair despite reduced LV end-diastolic diameter (LVEDD) and LV end-systolic diameter (LVESD), whereas in others an improvement in LVEF was shown. One study suggests reverse remodeling only in patients with lower values of logistic EuroSCORE and STS scores, LV end-diastolic volume index (LVEDVi), right ventricular end systolic area, and pulmonary artery systolic pressure (PAPs) at baseline evaluation and in multivariate analysis, only PAPs remained an independent predictor of improvement. Another study utilizing cardiovascular magnetic resonance to assess extent and predictors of reverse remodeling (defined by reduction of LVEDVi>15% compared to baseline) demonstrated improvement in only 34% of the patients, predicted by improvement in MR volume and MR fraction. In the landmark Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation (The COAPT Trial), LVEF had deteriorated following both repair and the control arm of medical therapy alone, albeit at a lower rate in patients treated with the MitraClip device (reduction of 5.6±1.2% versus 8.8±1.1%, p=0.048).

It was shown, in a few preliminary trials, that a significant number of patients undergoing transcatheter mitral edge-to-edge repair suffer from an acute reduction in left ventricular function. This so called "afterload mismatch" resulted in worsened prognosis in this patient population, as compared with controls.

Nevertheless, the information available in the current literature is limited and based on relatively smaller studies. We therefore wish to learn more about patients undergoing transcatheter mitral edge-to-edge repair, encompassing both primary and secondary mitral regurgitation, assess dynamics in left ventricular function during and after the admission, identify predictors of an acute reduction in left ventricular function and understand its impact on prognosis.

In this international, multicenter registry, consecutive patients undergoing TEER are included. We aim to assess changes in LVEF and LV end-diastolic volume (LVEDV) immediately after the procedure. We will then assess rates of AM, defined as a reduction of >15% in LVEF or an increase of >15% in LVEDV, its impact on all-cause mortality, MACE (composite end point of all-cause death, surgery and grade 3+ or 4+ mitral regurgitation) and LVEF at 12 months, as well as predictors for AM.

Study Type

Observational

Enrollment (Anticipated)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
    • HaMerkaz
      • Petah-Tikva, HaMerkaz, Israel, 49100
        • Recruiting
        • Rabin Medical Center
        • Contact:
        • Sub-Investigator:
          • Ran Kornowski, ND

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 120 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients undergoing TEER using the MitraClip percutaneous mitral valve repair (Abbott Vascular, Inc., Santa Clara, California) are included.

Description

Inclusion Criteria:

-

Exclusion Criteria:

  • patients who are taken immediately to surgery following the procedure
  • those who did not have echocardiographic information in the first 30 days post TEER
  • patients who have undergone combined mitral and tricuspid repair
  • severe non-cardiovascular diseases such as systemic infection or malignancy
  • cardiogenic shock presenting at baseline

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 12 months
Rates of all cause death
12 months
MACE
Time Frame: 12 months
Rates of major adverse cardiac events (MACE= a composite of death, need for mitral surgery or percutaneous repair and rates of grade 3+ or 4+ mitral regurgitation)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LV Function and size
Time Frame: 12 months
12-month LVEF and LVEDV
12 months
NYHA
Time Frame: 12 months
New York Heart Association (NYHA) classification
12 months
Heart failure admissions
Time Frame: 12 months
Number of heart failure admissions
12 months
Need for mitral surgery or percutaneous repair
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Anticipated)

August 1, 2022

Study Completion (Anticipated)

August 1, 2022

Study Registration Dates

First Submitted

March 28, 2022

First Submitted That Met QC Criteria

March 28, 2022

First Posted (Actual)

April 5, 2022

Study Record Updates

Last Update Posted (Actual)

April 5, 2022

Last Update Submitted That Met QC Criteria

March 28, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RMC-18-0352

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe