Clinical trial NCT04475315: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Heart Failure
Cardiomyopathy, Dilated
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2020-07-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in left ventricular function as assessed by LVEF
timeFrame: Baseline, up to 5 years
measure: Change in left ventricular volume
timeFrame: Baseline, up to 5 years
Secondary outcomes:
measure: Mortality Rate
timeFrame: 5 years
measure: Number of Major Adverse Cardiac Events (MACE)
timeFrame: 5 years
measure: Percentage of participants at each FMR severity grade
timeFrame: Baseline, up to 5 years
measure: Change in MLHF Questionnaire Score
timeFrame: Baseline, up to 5 years
measure: Change in Functional Status as assessed by 6MWT
timeFrame: Baseline, up to 5 years
measure: All Cause Readmission Rate
timeFrame: 5 years
measure: Heart Failure Readmission Rate
timeFrame: 5 years
measure: Incidence of Mitral Leaflet Tenting
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
affiliation: University of Miami
name: Joseph Lamelas, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.