Ventricular Sling for Heart Failure With Reduced Ejection Fraction

NCT04475315 | Withdrawn FDA Device

• 1 other identifier: 20200679
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Heart Failure; Cardiomyopathy, Dilated

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Mortality Rate

  5 years

• Number of Major Adverse Cardiac Events (MACE)

  5 years

• Percentage of participants at each FMR severity grade

  Baseline, up to 5 years

• Change in MLHF Questionnaire Score

  Baseline, up to 5 years

• Change in Functional Status as assessed by 6MWT

  Baseline, up to 5 years

Study Arms (2)

Papillary Muscle Sling Group

EXPERIMENTAL

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; Procedure: CABG surgery

Controls Group

ACTIVE COMPARATOR

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

Procedure: CABG surgery

Interventions

Papillary Muscle Sling 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.

Papillary Muscle Sling Group

CABG surgery 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; Papillary Muscle Sling Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Miami: lead

Related Publications (2)

• 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.

  PMID: 24364086 BACKGROUND

• 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.

  PMID: 23545430 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Cardiomyopathy, Dilated

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Cardiomegaly; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Joseph Lamelas, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief and Program Director of Cardiothoracic Surgery

Study Record Dates

• First Submitted: July 10, 2020
• First Posted: July 17, 2020
• Study Start: December 12, 2021
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 11, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share