Paracor Ventricular Support System (PVSS) for Patients With Heart Failure (PEERLESS-HF)

• Death or Additional Surgical Session at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  

• Implant Success (Number of Participants Successfully Implanted) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  "Implant success" refers to the ability to successfully deliver a device onto the epicardial surface and leave the device in a satisfactory position.
  
  
• Change in NYHA Functional Class [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
  Change in NYHA functional class between baseline and 6 months. "Maintained" means the participant's functional class remains the same as baseline. "Improved" means the participant's functional class has improved (become lower in number) by at least one class. "Worsened" means the participatn's functional class has deteriorated (become higher in number) by at least one class.
  
  
• Changes in Left Ventricular Diameters [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
  Mean change in left ventricular end-diastolic diameter (LVEDD) and left ventricular end-systolic diameter (LVESD) from baseline to 6 months (echocardiographic measurements)
  
  
• Changes in Left Ventricular Volumes [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
  Mean change in left ventricular end-diastolic volume (LVEDv) and left ventricular end-systolic volume (LVESV) from baseline to 6 months (echocardiographic measurements)
  
  
• Change in Left Ventricular Ejection Fraction [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
  Mean change in left ventricular ejection fraction from baseline to 6 months (echocardiographic measurements)
  
  
• Change in Left Ventricular Mass [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
  Mean change in left ventricular mass from baseline to 6 months (echocardiogram measurements)
  
  
• Changes in 6 Minute Walk [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
  Mean change in 6 minute walk distance (meters) between baseline and 6 months
  
  
• Changes in Cardiopulmonary Tests [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
  Mean change in Peak VO2 (ml/kg/min) between baseline and 6 months
  
  
• Mean Changes in Overall Minnesota Living With Heart Failure (MLHF) Quality of Life Questionnaire Score [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
  The MLHF Quality of Life (QOL) Questionnaire evaluates the effects of heart failure on a subject's physical, emotional, social and mental dimensions of quality of life. Each of 21 questions is scored as to how much heart failure has impacted the subject, from 0-no impact to 5-very much (overall score can range from 0 to 105). Prior studies have shown a 10-point improvement (10-point decrease in overall score) correlated with a 1 NYHA class improvement, and 10-point worsening (10-point increase in score) was associated with a higher risk of hospitalization or death.
  
  
• Number of Adverse Events [ Time Frame: Study duration ] [ Designated as safety issue: Yes ]
  Total adverse events reported prior to study closure
  
  
• Number of Participants Who Died [ Time Frame: Study duration ] [ Designated as safety issue: Yes ]
  Total number of patient deaths reported prior to study closure
  
  

Device: Placement of the PVSS Implant
Implant is placed on epicardial surface of the heart surrounding both the right and left ventricles, to provide mechanical support to the ventricular walls.
Other Names:
• HeartNet
• Ventricular support device
• Ventricular elastic support therapy

Please refer to brief summary.