Trial Outcomes & Findings for Wave Crossover ECP Study for Simplified Therapy (NCT NCT06571370)

60 subjects screened - 8 screen fails = 52 subjects randomized

Wave Crossover ECP Study for Simplified Therapy

The primary effectiveness endpoint was the average Diastolic Augmentation (DA) ratio for the 8th minute of compressions with each ECP device tested for each participant, as identified by the blinded Independent Waveform Evaluator. Diastolic Augmentation (DA) ratio, also referred to as Diastolic/Systolic (D/S) ratio and Effectiveness Ratio (ER), noninvasively characterizes the hemodynamic effect and thus the clinical effectiveness of ECP treatment. DA ratio is a unitless measure which is "calculated as the ratio of the peak diastolic amplitude divided by the peak systolic amplitude" \[Suresh et al., 1998\]. In a typical, non-augmented, cardiac cycle, the diastolic peak is seen as a small increase in the arterial waveform just after the aortic valve closes (dicrotic notch). With augmentation, the peak diastolic amplitude is distinctly elevated and may reach a significant proportion of the peak systolic amplitude or in some cases exceed it.

The level of systolic unloading was recorded based on the systolic peaks during compressions compared to baseline PPG data. Systolic unloading is the percent change of peak systolic amplitude calculated as the difference of the compression waveform - non-compressed baseline waveform divided by amplitude at compression waveform. Systolic unloading components were measured using the peak systolic amplitude on the last compression waveform from the ECP session. The baseline non-compressed peak systolic amplitude was measured from the waveform immediately following the compressed waveform. Higher levels of systolic unloading are considered better. The predicate devices are documented to produce mean systolic unloading of approximately 11%.

Systolic unloading is the ratio of the systolic peak during compressions divided by baseline systolic peak. Systolic unloading is represented by a percentage decrease of systolic peak value with and without compression. This value should be \< 1. The baseline systolic peaks after compressions will be used. Higher levels of systolic unloading are considered better. The predicate devices are documented to produce mean systolic unloading of approximately 11%.