Papillary Muscle Sling for Improved Ventricular Function in Heart Failure
This study aims to evaluate the impact of a Papillary Muscle Sling on improving ventricular function in heart failure patients, by assessing changes in left ventricular ejection fraction and left ventricular volume through echocardiograms.
Papillary Muscle Sling
+ CABG surgery
Laminopathies+6
+ Cardiomyopathy, Dilated
+ Cardiovascular Diseases
Treatment Study
Summary
Study start date: December 12, 2021
Actual date on which the first participant was enrolled.This study focuses on a treatment approach for heart failure with reduced ejection fraction, a condition where the heart's lower chamber doesn't pump blood effectively. The treatment involves a procedure called Left Ventricular Papillary Muscle Sling. This technique brings together the walls of the heart's lower chamber at the base of the papillary muscles. It's been used before with mitral valve surgery and has shown significant patient benefits. The goal is to improve heart function, slow down the worsening of heart chamber enlargement, and prevent the progression of mitral regurgitation (a condition where the mitral valve doesn't close properly) in patients with symptomatic heart chamber enlargement. During the study, participants will undergo the Papillary Muscle Sling procedure. The effects of this procedure will be measured by changes in left ventricular function and volume. These changes will be assessed using an echocardiogram, a type of ultrasound test that uses high-pitched sound waves sent through a device called a transducer to produce images of the heart. The study will evaluate the end systolic and end diastolic left ventricular volumes, which are the amounts of blood in the left ventricle at the end of its contraction and relaxation phases, respectively. The study will also measure the Left Ventricular Ejection Fraction (LVEF), which is the percentage of blood that leaves the heart each time it contracts, indicating how effectively the heart is pumping.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: Patients with symptomatic heart failure with reduced ejection fraction and either ischemic or non-ischemic cardiomyopathies, referred for CABG surgery. Suitability for the ventricular sling procedure is determined by the surgeon and or cardiologist, using some or all the criteria described below: * Left ventricular end diastolic diameter is greater than or equal to 55mm. * Ejection fraction ≥20% and ≤40% * FMR grade ≤ 2+ (≤ mild FMR) as defined by the guidelines of the American society of echocardiography at the time of the study approval (via a transthoracic or transesophageal echo). * End-systolic Interpapillary muscle distance ≥ 20mm * Cardiomyopathy of ischemic or non-ischemic origins. * Able to sign informed consent and release of medical information forms, or able to assign a legal representative who can sign on the patient's behalf. Exclusion Criteria: * Any evidence of structural (chordal or leaflet) mitral lesions. * Planned concomitant intra-operative procedures (except for closure of patent foramen ovale or atrial septal defect or coronary revascularization) * Planned concomitant intra-operative Maze procedure for symptomatic paroxysmal atrial fibrillation. * Persistent atrial fibrillation * Prior mitral valve repair * Contraindication for cardiopulmonary bypass * Clinical signs of cardiogenic shock * ST segment elevation myocardial infarction within 14 days prior to inclusion in this study. * Congenital heart disease (except PFO or ASD) * Chronic renal insufficiency defined by Creatinine ≥ 3.0 or chronic renal replacement therapy, who are contraindicated for cardiac surgery * Recent history of psychiatric disease that is likely to impair compliance with the study protocol, in the judgement of the investigator * Pregnancy
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives