Strain Imaging in Patients With Functional Mitral Regurgitation, Treated With MitraClip

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-10

Study Completion Date

2019-05-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of this study is i) to evaluate left ventricular global longitudinal strain and myocardial work in patients with heart failure and severe functional mitral regurgitation one year after MitraClip implantation and compare these variables with patients treated with optimal medical treatment and ii) to find echocardiographic predictors of clinical response and reverse left ventricular remodeling at one-year follow up.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Clinical Evaluation of the Safety and Effectiveness of the MitraClip System in the Treatment of Clinically Significant Functional Mitral Regurgitation

NCT02444338

Mitral Valve Insufficiency

COMPLETED NA

Evaluation of Outcomes of CRT and MitraClip for Treatment of Low Ejection Fraction and Functional Mitral Regurgitation in HF

NCT02985268

Functional Mitral Regurgitation Heart Failure

WITHDRAWN NA

Mitral Regurgitation Treatment in Advanced Heart Failure

NCT05292716

Heart Failure Mitral Regurgitation

RECRUITING NA

Unmasking the dynAmic Component in functionaL mitraL rEGuRgitatiOn in Chronic Heart Failure

NCT03315429

Heart Failure

UNKNOWN NA

A Feasibility Study of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation

NCT04147884

Mitral Regurgitation Functional Mitral Valve Disease Cardiovascular Diseases

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study is one of the first in terms of publication. As far as the investigators know there are few papers with small series of patients regarding echocardiographic parameters and strain imaging in patients with functional mitral regurgitation (MR) and MitraClip. As the investigator's goal is to assess the potential impact of the MitraClip on myocardial deformation indexes, at the end of the study a direct comparison of changes of echocardiography markers -at one year follow up- between the control and device group will be performed. The changes in myocardial deformation markers will be associated with the respective changes in Brain-natriuretic peptide (BNP) levels, New York Heart Association (NYHA) class status, 6-minute walking distance (6MWD) and left ventricle (LV) volumes at follow -up. The investigators also aim to identify baseline prognostic echocardiography markers for the prediction of clinical improvement and LV reverse remodeling after successful edge-to-edge repair in functional MR patients during one year follow up. In specific, in this study the investigators will measure the 2-Dimension (2D) strain values of the left ventricle and left atrium (global longitudinal strain-GLS of the LV and Peak Atrial longitudinal strain - PALS of the left atrium) at baseline and at one year follow up, they will appreciate the LV myocardial work and all its components (Global Work Index-GWI, Global Constructed Work-GCW,Global wasted work-GWW and Global Work Efficiency-GWE) of the left ventricle and finally they will evaluate the baseline variables as predictors of reverse LV remodeling defined by reduction of left ventricle end-diastolic and end-systolic volume at one-year follow up.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mitral Regurgitation Heart Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Device group

patients with heart failure and concomitant severe functional mitral regurgitation that were treated with MitraClip

speckle tracking analysis of transthoracic echocardiogram

Intervention Type DIAGNOSTIC_TEST

analysis at workstation with 2D strain-Speckle tracking echocardiography of transthoracic cardiac echo at baseline and one-year follow up examination

Control group

patients with heart failure and concomitant severe functional mitral regurgitation that were treated with optimal medical treatment

speckle tracking analysis of transthoracic echocardiogram

Intervention Type DIAGNOSTIC_TEST

analysis at workstation with 2D strain-Speckle tracking echocardiography of transthoracic cardiac echo at baseline and one-year follow up examination

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

speckle tracking analysis of transthoracic echocardiogram

analysis at workstation with 2D strain-Speckle tracking echocardiography of transthoracic cardiac echo at baseline and one-year follow up examination

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* patients with EF more than 15% and below 45%
* Heart failure symptoms with NYHA class \>2
* Moderate-to-severe and severe functional Mitral regurgitation

Exclusion Criteria

* degenerative mitral regurgitation
* asymptomatic patients
* NYHA class IV patients not able to perform 6MWT
* EF\>45%
* poor echocardiographic acoustic window patients

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No