Efficacy, Safty, Device
Conditions
Brief summary
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.
Detailed description
MACCE includes all-cause death, myocardial infarction, stroke and any elective or emergency cardiac or thoracic aortic surgery or catheter-based interventional therapy.
Interventions
DEVICEpercutaneous ventricular restoration using heartech® device
Patients who are confirmed suitability by imaging analysis, receive heartech® left ventricular partitioning device implantation.
Sponsors
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* BMI\<40; * left ventricular ejection fraction ≤45% and ≥20%; * patients with left ventricular end-systolic volume index (ESVI) ≥50mL/m2; * transthoracic ultrasound showed contradictory motion of the left ventricle after myocardial infarction; * 60 days prior to anterior wall myocardial infarction with ischemic heart failure (NYHA grade II to not hospitalized grade IV); * the left ventricle must have the appropriate anatomic structure (size and shape) which is confirmed by cardiac CT and left ventricular angiography to implant the appropriate Heartech® device; * agree to receive reasonable treatment according to current ACC/AHA and Chinese guidelines for heart failure diagnosis and treatment; * the subjects or their legal representatives are informed of the nature of this study and agree to participate in all the terms of this study, sign the informed consent approved by the ethics committee, agree to accept the postoperative treatment plan and follow-up requirements, and can complete the examination of follow-up.
Exclusion criteria
* patients whose left ventricular anatomy is not suitable for Heartech® occlusal device implantation; * the abnormal ventricular wall movement not contains the anterior wall of the left ventricle, the apex of the left ventricle and the ventricular septum; * patients with thrombosis in the left ventricle; * mitral stenosis or regurgitation (tricuspid, aortic or mitral) \> 2+ (moderate); * recent (within 6 month) cerebrovascular accident (CVA) or transient ischemic attack (TIA); * end-stage renal disease requiring long-term dialysis, episodic sepsis or active phase endocarditis; * life expectancy at admission \< 1 year; * known allergy to aspirin, heparin, warfarin, Nitinol (alloys of titanium and nickel) or contraindications, or sensitivity to contrast agents; * cardiogenic shock occurred within 72 hours before procedure; * pregnancy or planned pregnancy during the study period; * participated in clinical trials of other drugs or medical devices during the same period; * the researcher judged that the patient had poor compliance and could not complete the study as required; * other conditions considered unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of MACCE [primary safety] | 30 days | major adverse cardiovascular events (MACCE) |
| LVESVi Reduction [primary efficacy] | 6 month | left ventricular systolic volume index (LVESVi) reduction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| LVEF change | 12 month | left ventricular ejection fraction (LVEF) detected by echocardiography |
| Cardiac function | 12 month | cardiac function evaluation (NYHA classification) |
| Walk tolerance | 12 month | 6 minutes walk test |
| Procedure Success | immediate | success rate of the procedure |
| life quality | 12 month | quality of life (EQ-5D) |
| Cardiac death | 12 month | cardiac death rate |
| Rehospitalization | 12 month | rehospitalization rate |
| Incidence of MACCE | 12 month | MACCE occurrence rate |
| LVESVi Reduction | 12 month | left ventricular end systolic volume index (LVESVi) change |
| Mortality | 12 month | all-cause mortality rate |
| LVEDVi Reduction | 12 month | left ventricular end-diastolic volume index (LVEDVi) |
Countries
China
Contacts
Primary ContactZhengbin Zhu, M.D Ph.D.
Outcome results
None listed