Ignite Creation Date:
2024-05-06 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 2:29 PM
Study NCT ID:
NCT05311163
Status:
UNKNOWN
Last Update Posted:
2022-04-05
First Post:
2022-03-28
Brief Title:
Change in LVEF Following Transcatheter Mitral Edge-To-Edge Repair
Sponsor:
Rabin Medical Center
Organization:
Rabin Medical Center
Study Overview
Official Title:
MITRA-EF A Multi-Center Registry Evaluating Left Ventricular Function in Patients Undergoing Transcatheter Mitral Edge-To-Edge Repair
Status:
UNKNOWN
Status Verified Date:
2022-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MITRA-EF
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
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 LVEDVi15 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 5612 versus 8811 p0048
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None