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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PVR implantation group | Experimental | Patients enrolled receive PVR intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| percutaneous ventricular restoration using heartech® device | Device | Patients who are confirmed suitability by imaging analysis, receive heartech® left ventricular partitioning device implantation. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of MACCE [primary safety] | major adverse cardiovascular events (MACCE) | 30 days |
| LVESVi Reduction [primary efficacy] | left ventricular systolic volume index (LVESVi) reduction | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure Success | success rate of the procedure | immediate |
| Mortality | all-cause mortality rate | 12 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhengbin Zhu, M.D Ph.D. | Contact | 021-64370045 | 673344 | zzb11561@rhj.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Fenghua Ding, MD. Ph.D. | Cardiovascular research instittion, Shanghai Jiao Tong University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200025 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31231944 | Background | 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(R) 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. |
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| Cardiac death | cardiac death rate | 12 month |
| Rehospitalization | rehospitalization rate | 12 month |
| Incidence of MACCE | MACCE occurrence rate | 12 month |
| LVESVi Reduction | left ventricular end systolic volume index (LVESVi) change | 12 month |
| LVEDVi Reduction | left ventricular end-diastolic volume index (LVEDVi) | 12 month |
| LVEF change | left ventricular ejection fraction (LVEF) detected by echocardiography | 12 month |
| Cardiac function | cardiac function evaluation (NYHA classification) | 12 month |
| Walk tolerance | 6 minutes walk test | 12 month |
| life quality | quality of life (EQ-5D) | 12 month |