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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
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.
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
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
Time frame: 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.
Time frame: Baseline, up to 5 years
Mortality Rate
Rate of reported mortality rate will be evaluated.
Time frame: 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
Time frame: 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.
Time frame: 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).
Time frame: Baseline, up to 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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).
Time frame: 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.
Time frame: 5 years
Heart Failure Readmission Rate
Heart failure readmission rate will be calculated for heart failure throughout the duration of study participation.
Time frame: 5 years
Incidence of Mitral Leaflet Tenting
Mitral Leaflet tenting will be evaluated using echocardiographic imaging.
Time frame: 5 years