Ventricular Sling for Heart Failure With Reduced Ejection Fraction

University of Miami

Status: Withdrawn

Conditions: Cardiomyopathy, Dilated; Heart Failure

Treatments: Procedure: CABG surgery; Device: Papillary Muscle Sling

Study type: Interventional

Funder types: Other

Identifiers

NCT04475315

20200679

Details and patient eligibility

About

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.

Full description

The Sling is used to draw together the ventricular walls at the base of the papillary muscles. This technique has previously been used in conjunction with mitral valve surgery, and has shown significant benefits for the patients.

The reduction in the lateral inter-papillary muscle separation and in the left ventricular volume provided by this technique is expected to improve ventricular function, limit progression of ventricular dilation, and avoid progression of MR when performed without mitral valve surgery in patients with symptomatic ventricular dilation.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 2 patient groups

Papillary Muscle Sling Group

Experimental group

Description:

Participants in the papillary muscle sling group will receive the sling technique performed in conjunction with their standard of care (SOC) Coronary Artery Bypass Grafting (CABG) surgery.

Treatment:

Device: Papillary Muscle Sling

Procedure: CABG surgery

Controls Group

Active Comparator group

Description:

Participants in the control group will receive their SOC CABG surgery only, without any additional intervention.

Treatment:

Procedure: CABG surgery