Ventricular Sling for Heart Failure With Reduced Ejection Fraction

NCT ID: NCT04475315

Last Updated: 2022-05-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-12
• Study Completion Date: 2027-12-31

Brief Summary

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.

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.

Conditions

Heart Failure; Cardiomyopathy, Dilated

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Papillary Muscle Sling

Intervention Type: DEVICE

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.

CABG surgery

Intervention Type: PROCEDURE

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

Controls Group

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

Group Type: ACTIVE_COMPARATOR

CABG surgery

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: DEVICE

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

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Joseph Lamelas

Chief and Program Director of Cardiothoracic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joseph Lamelas, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

References

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.

Reference Type: BACKGROUND

PMID: 24364086 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23545430 (View on PubMed)

Other Identifiers

20200679

Identifier Type: -

Identifier Source: org_study_id