Efficacy, Safty, Device Clinical Trial
— ParticalOfficial 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.
| Status | Recruiting |
| Enrollment | 117 |
| Est. completion date | July 31, 2022 |
| Est. primary completion date | July 31, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| China | Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai |
| Lead Sponsor | Collaborator |
|---|---|
| Shanghai Jiao Tong University School of Medicine |
China,
Zhu Z, Yu J, Xu K, Tang Y, Fang Y, Gu J, Gu S, Ding F, Modine T, Zhang R. First-in-man study of Heartech® percutaneous left ventricular partitioning device for treatment of heart failure postmyocardial infarction. Catheter Cardiovasc Interv. 2019 Nov 15;94(6):845-853. doi: 10.1002/ccd.28366. Epub 2019 Jun 23. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of MACCE [primary safety] | major adverse cardiovascular events (MACCE) | 30 days | |
| Primary | LVESVi Reduction [primary efficacy] | left ventricular systolic volume index (LVESVi) reduction | 6 month | |
| Secondary | Procedure Success | success rate of the procedure | immediate | |
| Secondary | Mortality | all-cause mortality rate | 12 month | |
| Secondary | Cardiac death | cardiac death rate | 12 month | |
| Secondary | Rehospitalization | rehospitalization rate | 12 month | |
| Secondary | Incidence of MACCE | MACCE occurrence rate | 12 month | |
| Secondary | LVESVi Reduction | left ventricular end systolic volume index (LVESVi) change | 12 month | |
| Secondary | LVEDVi Reduction | left ventricular end-diastolic volume index (LVEDVi) | 12 month | |
| Secondary | LVEF change | left ventricular ejection fraction (LVEF) detected by echocardiography | 12 month | |
| Secondary | Cardiac function | cardiac function evaluation (NYHA classification) | 12 month | |
| Secondary | Walk tolerance | 6 minutes walk test | 12 month | |
| Secondary | life quality | quality of life (EQ-5D) | 12 month |