Change in LVEF Following Transcatheter Mitral Edge-To-Edge Repair

NCT ID: NCT05311163

Last Updated: 2022-04-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 4000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2022-08-01

Brief Summary

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.

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.

Conditions

Mitral Regurgitation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Interventions

MitraClip

Transcatheter Mitral Edge-To-Edge Repair

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rabin Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rabin Medical Center

Petah Tikva, Central District, Israel

Site Status: RECRUITING

Countries

Israel

Facility Contacts

Leor Perl

Role: primary

leorperl@gmail.com

039372460

References

Perl L, Kheifets M, Guido A, Agricola E, Denti P, Wild MG, Praz F, Rubbio AP, Bedogni F, De Marco F, Beeri R, Shuvy M, Melillo F, Montorfano M, Freixa X, de la Fuente Mancera JC, Giordano A, Finizio F, Van Mieghem NM, Ooms JFW, Fam N, O'Connor C, Toggweiler S, Levi A, Shapira Y, Schwartzenberg S, Pidello S, D'Ascenzo F, Angelini F, Haberman D, Crimi G, Porto I, Cozzi O, Giannini F, Tarantini G, Maisano F, Kornowski R; MITRA-EF study *. Acute Reduction in Left Ventricular Function Following Transcatheter Mitral Edge-to-Edge Repair. J Am Heart Assoc. 2023 Jul 4;12(13):e029735. doi: 10.1161/JAHA.123.029735. Epub 2023 Jun 22.

Reference Type: DERIVED

PMID: 37345813 (View on PubMed)

Other Identifiers

RMC-18-0352

Identifier Type: -

Identifier Source: org_study_id