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Ventricular Sling for Heart Failure With Reduced Ejection Fraction

Primary Purpose

Heart Failure, Cardiomyopathy, Dilated

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Papillary Muscle Sling

CABG surgery

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Papillary Muscle Sling Group

Controls Group

Arm 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.

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

Outcomes

Primary Outcome Measures

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

Change in left ventricular volume

End systolic and end diastolic left ventricular volumes will both be evaluated in mL using echocardiogram.

Secondary Outcome Measures

Mortality Rate

Rate of reported mortality rate will be evaluated.

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

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.

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).

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).

All Cause Readmission Rate

All cause readmission rate will be calculated for any case throughout the duration of study participation.

Heart Failure Readmission Rate

Heart failure readmission rate will be calculated for heart failure throughout the duration of study participation.

Incidence of Mitral Leaflet Tenting

Mitral Leaflet tenting will be evaluated using echocardiographic imaging.

Full Information

NCT ID

NCT04475315

First Posted

July 10, 2020

Last Updated

May 5, 2022

Sponsor

University of Miami

1. Study Identification

Unique Protocol Identification Number

NCT04475315

Brief Title

Ventricular Sling for Heart Failure With Reduced Ejection Fraction

Official Title

Left Ventricular Papillary Muscle Sling for Heart Failure With Reduced Ejection Fraction (Papillary Muscle Sling)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Withdrawn

Why Stopped

Difficulty with recruitment

Study Start Date

December 12, 2021 (Anticipated)

Primary Completion Date

December 2027 (Anticipated)

Study Completion Date

December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Miami

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure, Cardiomyopathy, Dilated

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Papillary Muscle Sling Group

Arm Type

Experimental

Arm 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.

Arm Title

Controls Group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Papillary Muscle Sling

Intervention Description

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

Procedure

Intervention Name(s)

CABG surgery

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in left ventricular function as assessed by LVEF

Description

Change in Left Ventricular Ejection Fraction (LVEF) will be reported as a change in percent ejection fraction assessed via echocardiogram

Time Frame

Baseline, up to 5 years

Title

Change in left ventricular volume

Description

End systolic and end diastolic left ventricular volumes will both be evaluated in mL using echocardiogram.

Time Frame

Baseline, up to 5 years

Secondary Outcome Measure Information:

Title

Mortality Rate

Description

Rate of reported mortality rate will be evaluated.

Time Frame

5 years

Title

Number of Major Adverse Cardiac Events (MACE)

Description

Time Frame

5 years

Title

Percentage of participants at each FMR severity grade

Description

Time Frame

Baseline, up to 5 years

Title

Change in MLHF Questionnaire Score

Description

Time Frame

Baseline, up to 5 years

Title

Change in Functional Status as assessed by 6MWT

Description

Functional status will be assessed as the distance reached in meters via the 6-minute Walk Test (6MWT).

Time Frame

Baseline, up to 5 years

Title

All Cause Readmission Rate

Description

All cause readmission rate will be calculated for any case throughout the duration of study participation.

Time Frame

5 years

Title

Heart Failure Readmission Rate

Description

Heart failure readmission rate will be calculated for heart failure throughout the duration of study participation.

Time Frame

5 years

Title

Incidence of Mitral Leaflet Tenting

Description

Mitral Leaflet tenting will be evaluated using echocardiographic imaging.

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joseph Lamelas, MD

Organizational Affiliation

University of Miami

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

24364086

Citation

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.

Results Reference

background

PubMed Identifier

23545430

Citation

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.

Results Reference

background

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Ventricular Sling for Heart Failure With Reduced Ejection Fraction

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