It is one of the secondary endpoints. The problem is they have so many of them that the statistics get muddy if they don't correct for multiple hypothesis testing - if you have 30 secondary endpoints and you don't correct for multiple hypothesis testing you can expect 1 or 2 to be significant just by chance. Like nearly all of MSB releases this one is very light on details.
Primary Outcome Measures :
Time to recurrent non-fatal decompensated heart failure major adverse cardiac events (HF-MACE) that occur prior to the first terminal cardiac event (TCE). [ Time Frame: 6 Month minimum ]
Time-to-hospital admissions for non-fatal decompensated HF events [ Time Frame: 6 Month minimum ]
Time-to-urgent care outpatient HF visits [ Time Frame: 6 Month minimum ]
Time-to-successfully resuscitated cardiac death (RCD) events [ Time Frame: 6 Month minimum ]
Total length of in-hospital stay in intensive care unit for non-fatal decompensated HF events [ Time Frame: 6 Month minimum ]
Time-to-first HF-MACE (composite of hospital admissions for decompensated HF, urgent care outpatient HF visit, and successfully RCD events) [ Time Frame: 6 Month minimum ]
Time-to-first HF-MACE (composite of hospital admissions for decompensated HF, urgent care outpatient HF visit, successfully RCD events or TCE) [ Time Frame: 6 Month minimum ]
Time-to-cardiac death [ Time Frame: 6 Month minimum ]
Time-to-all-cause death [ Time Frame: 6 Month minimum ]
Time-to-first non-fatal MI (myocardial infarction), non-fatal CVA (cerebrovascular attack) or coronary artery revascularization [ Time Frame: 6 Month minimum ]
Left Ventricular (LV) remodeling in LVESV determined by 2-D echocardiography [ Time Frame: Screening, day 0 (post-procedure), months 3, 6, and 12, and every 12 months thereafter during study conduct (6 Month minimum) ]
Correlations between baseline LVESV <=100 mL and LVESV >100 mL and clinical outcomes [ Time Frame: 6 Month minimum ]
Correlations between baseline LVESV <=100 mL and LVESV >100 mL and change in Month 6 to baseline LVESV and clinical outcomes [ Time Frame: 6 Month minimum ]
LV remodeling in LVEDV determined by 2-D echocardiography [ Time Frame: Screening, day 0 (post-procedure), months 3, 6, and 12, and every 12 months thereafter during study conduct (6 Month minimum) ]
Overall Left Ventricular systolic performance as assessed by LVEF (RVG or echocardiogram) [ Time Frame: Screening, day 0 (post-procedure), months 3, 6, and 12, and every 12 months thereafter during study conduct (6 Month minimum) ]
Functional exercise capacity as assessed by 6 Minute Walk Test [ Time Frame: Screening, months 3, 6, and 12, and every 12 months thereafter during study conduct (6 Month minimum) ]
Functional status by New York Heart Association (NYHA) class [ Time Frame: Screening, months 3, 6, and 12, and every 12 months thereafter during study conduct (6 Month minimum) ]
Quality of Life Measure - Minnesota Living With Heart Failure (MLHF) questionnaire [ Time Frame: Screening, months 3, 6, and 12, and every 6 months thereafter during study conduct (6 Month minimum) ]
Quality of Life Measure - EuroQoL 5-dimensional (EQ-5D) questionnaire [ Time Frame: Screening, months 3, 6, and 12, and every 6 months thereafter during study conduct (6 Month minimum) ]
Safety as assessed by occurrence of adverse events related to the index cardiac catheterization on Day 0 [ Time Frame: Day 0 through discharge from Day 0 hospitalization ]
Safety as assessed by occurrence of treatment-emergent adverse events [ Time Frame: Screening through 6 Month minimum ]
Safety as assessed by clinical laboratory tests (serum chemistry - ALT, AST, alkaline phosphate, GGT, LDH, BUN, creatinine, uric acid, total bilirubin - and hematology - hematocrit, hemoglobin, WBC, eosinophils, ANC, platelet count) [ Time Frame: Screening, day 0 (post-procedure), day 10, months 1, 3, 6, and 12, and every 6 months thereafter during study conduct (6 Month minimum) ]
Safety as assessed by urinalysis (blood, glucose, ketones, total protein) [ Time Frame: Screening, day 10, months 1, 3, 6, and 12, and every 6 months thereafter during study conduct (6 Month minimum) ]
Safety as assessed by vital signs (pulse, systolic BP, diastolic BP) [ Time Frame: Screening, day 0 (pre and post-procedure), day 1, day 10, months 1, 3, 6, and 12, and every 6 months thereafter during study conduct (6 Month minimum) ]
Safety as assessed by 12-lead electrocardiogram (ECG) findings - QTcF, QTcB, QT, QRS complex, HR and T waves. [ Time Frame: Screening, day 0 (pre and post-procedure), day 1, day 10, months 1, 3, 6, and 12, and every 6 months thereafter during study conduct (6 Month minimum) ]
Safety as assessed by telemetry monitoring findings (clinically significant arrhythmias) [ Time Frame: Day 0 through Day 0 overnight post-procedure ]
Safety as assessed by rhythm analysis (specifically, ventricular arrhythmias) by interrogation of any implanted device capable of defibrillation [ Time Frame: Day 10, months 1, 3, 6, and 12, and every 6 months thereafter during study conduct (6 Month minimum) ]
Safety as assessed by 24-hr Holter monitoring (HR, rate & duration of arrhythmias, a-fib average rate, supra- & ventricular ectopy singles/couplets/runs/totals, sustained & non-sustained ventricular tachycardia, longest pauses RR duration, total pauses) [ Time Frame: Screening, day 0 (post-procedure), day 10, months 1 and 3 ]
Safety as assessed by physical examination findings judged as clinically significant changes from baseline by the investigator or newly occurring abnormalities (including weight) [ Time Frame: Screening, month 12 and every 12 months thereafter until study conclusion (weight measured at screening, day 0 - pre and post-procedure, day 1, day 10, months 1, 3, 6 and 12 and every 6 months thereafter) ]
Safety as assessed by important cardiovascular events from adjudicated data [ Time Frame: 6 Month minimum ]
MSB Price at posting:
$3.85 Sentiment: Hold Disclosure: Held
(20min delay)