Efficacy, Safty, Device Clinical Trial
Official title:
Efficacy And Safty of Heartech® Left Ventricular Partitioning Device In Treating Heart Failure Post Myocardial Infarction (Phase II Clinical Trial: The Partical Study)
This is a prospective, multi-center, single-group, target-value clinical study. The primary
safety end points are major adverse cardiovascular events (MACCE) 30 days after device
implantation.
The primary efficacy end point is the end of left ventricular systolic volume index (LVESVI)
reduction at 6 month.
The secondary observational end points includes immediate success rate of the procedure,
all-cause mortality, cardiac death, rehospitalization rates and MACCE occurrence rate within
12 month. Besides, left ventricular end systolic volume index (LVESVI) change at 30 days,12
months, left ventricular ejection fraction (LVEF), left ventricular end-diastolic volume
index (LVEDVI), 6 minutes walk test, heart function evaluation (NYHA classification) and
quality of life (EQ-5D) at 30 days, 6 months, 12 months will also be evaluated.
After statistical hypothesis and sample size estimation, the sample size of this clinical
trial was 117 cases. All subjects were followed up 30 days, 6 months and 12 months after
implantation of the Heartech® left ventricular partitioning device. All relevant clinical
data were managed by professional data management center, and all relevant clinical data were
statistically analyzed by third-party statistical center.
MACCE includes all-cause death, myocardial infarction, stroke and any elective or emergency cardiac or thoracic aortic surgery or catheter-based interventional therapy. ;