Ventricular Sling for Heart Failure With Reduced Ejection Fraction

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.

Study Overview

• Status: Withdrawn
• Conditions: Heart Failure; Cardiomyopathy, Dilated
• Intervention / Treatment: Device: Papillary Muscle Sling; Procedure: CABG surgery

Detailed 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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Papillary Muscle Sling Group; 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.	Device: Papillary Muscle Sling; The sling is made of a Gore-Tex sheet or by using a 4 mm Gore-Tex vascular graft implanted around the base of the papillary muscles and tightened.; Procedure: CABG surgery; Standard of care Coronary Artery Bypass Grafting (CABG) surgery will be performed to improve blood flow to the heart by bypassing the narrowed segment of a severely diseased coronary artery
Active Comparator: Controls Group; Participants in the control group will receive their SOC CABG surgery only, without any additional intervention.	Procedure: CABG surgery; Standard of care Coronary Artery Bypass Grafting (CABG) surgery will be performed to improve blood flow to the heart by bypassing the narrowed segment of a severely diseased coronary artery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in left ventricular function as assessed by LVEF	Change in Left Ventricular Ejection Fraction (LVEF) will be reported as a change in percent ejection fraction assessed via echocardiogram	Baseline, up to 5 years
Change in left ventricular volume	End systolic and end diastolic left ventricular volumes will both be evaluated in mL using echocardiogram.	Baseline, up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality Rate	Rate of reported mortality rate will be evaluated.	5 years
Number of Major Adverse Cardiac Events (MACE)	MACE is defined as a composite of clinical events comprised of death, stroke, worsening heart failure defined as +1 New York Heart Association (NYHA) class, Congestive Heart Failure (CHF) hospitalization and mitral valve intervention as evaluated by treating physician	5 years
Percentage of participants at each FMR severity grade	Functional Mitral Regurgitation (FMR) severity is graded on a scale of 1 to 4 with 1 = none, 2 =mild, 3 = moderate and 4 =severe. This outcome will report the percentage of participants with reported none, mild, moderate or severe mitral regurgitation as assessed via echocardiogram by treating physician.	Baseline, up to 5 years
Change in MLHF Questionnaire Score	Minnesota Living with Heart Failure (MLHF) is a 21-item questionnaire with a total score ranging from 0 (indicating heart failure has no affect to life) to 105 (indicating the greatest affect to life).	Baseline, up to 5 years
Change in Functional Status as assessed by 6MWT	Functional status will be assessed as the distance reached in meters via the 6-minute Walk Test (6MWT).	Baseline, up to 5 years
All Cause Readmission Rate	All cause readmission rate will be calculated for any case throughout the duration of study participation.	5 years
Heart Failure Readmission Rate	Heart failure readmission rate will be calculated for heart failure throughout the duration of study participation.	5 years
Incidence of Mitral Leaflet Tenting	Mitral Leaflet tenting will be evaluated using echocardiographic imaging.	5 years

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Joseph Lamelas, MD, University of Miami

Publications and helpful links

General Publications

• Lamelas J, Mihos C, Santana O. Surgical technique: papillary muscle sling for functional mitral regurgitation during minimally invasive valve surgery. Heart Surg Forum. 2013 Oct;16(5):E295-7. doi: 10.1532/hsf98.2013209.
• Santana O, Solenkova NV, Pineda AM, Mihos CG, Lamelas J. Minimally invasive papillary muscle sling placement during mitral valve repair in patients with functional mitral regurgitation. J Thorac Cardiovasc Surg. 2014 Jan;147(1):496-9. doi: 10.1016/j.jtcvs.2013.03.006. Epub 2013 Mar 29.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 12, 2021
• Primary Completion (Anticipated): December 1, 2027
• Study Completion (Anticipated): December 1, 2027

Study Registration Dates

• First Submitted: July 10, 2020
• First Submitted That Met QC Criteria: July 14, 2020
• First Posted (Actual): July 17, 2020

Study Record Updates

• Last Update Posted (Actual): May 11, 2022
• Last Update Submitted That Met QC Criteria: May 5, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Genetic Diseases, Inborn; Cardiomegaly; Laminopathies; Heart Failure; Cardiomyopathies; Cardiomyopathy, Dilated
• Other Study ID Numbers: 20200679

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes