Ventricular Sling for Heart Failure With Reduced Ejection Fraction
Reason given: Difficulty with recruitment
Trial details
- Who runs it
- University of Miami
- Trial code
- NCT04475315
- Record updated
- 11 May 2022
- Original description
The purpose of this research is to investigate the effect of using this surgical technique in conjunction with bypass surgery to improve heart function and size, as well as decrease the possibility of future mitral valve surgery.Read full original descriptionShow less
Left Ventricular Papillary Muscle Sling for Heart Failure With Reduced Ejection Fraction (Papillary Muscle Sling)
The purpose of this research is to investigate the effect of using this surgical technique in conjunction with bypass surgery to improve heart function and size, as well as decrease the possibility of future mitral valve surgery.
Inclusion: 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: 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; Prior mitral valve repair; ST segment elevation myocardial infarction within 14 days prior to inclusion in this study; Congenital heart disease (except PFO or ASD); Recent history of psychiatric disease that is likely to impair compliance with the study protocol, in the judgement of the investigator; Chronic renal insufficiency defined by Creatinine ≥ 3.0 or chronic renal replacement therapy, who are contraindicated for cardiac surgery; Any evidence of structural (chordal or leaflet) mitral lesions; Persistent atrial fibrillation; Contraindication for cardiopulmonary bypass; Clinical signs of cardiogenic shock; Pregnancy.