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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
117
Patients who are confirmed suitability by imaging analysis, receive heartech® left ventricular partitioning device implantation.
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGIncidence of MACCE [primary safety]
major adverse cardiovascular events (MACCE)
Time frame: 30 days
LVESVi Reduction [primary efficacy]
left ventricular systolic volume index (LVESVi) reduction
Time frame: 6 month
Procedure Success
success rate of the procedure
Time frame: immediate
Mortality
all-cause mortality rate
Time frame: 12 month
Cardiac death
cardiac death rate
Time frame: 12 month
Rehospitalization
rehospitalization rate
Time frame: 12 month
Incidence of MACCE
MACCE occurrence rate
Time frame: 12 month
LVESVi Reduction
left ventricular end systolic volume index (LVESVi) change
Time frame: 12 month
LVEDVi Reduction
left ventricular end-diastolic volume index (LVEDVi)
Time frame: 12 month
LVEF change
left ventricular ejection fraction (LVEF) detected by echocardiography
Time frame: 12 month
Cardiac function
cardiac function evaluation (NYHA classification)
Time frame: 12 month
Walk tolerance
6 minutes walk test
Time frame: 12 month
life quality
quality of life (EQ-5D)
Time frame: 12 month
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.