NCT04039256

Phase II Clinical Trial of Percutaneous Ventricular Restoration Using Heartech® Device Preventing Heart Failure Post Myocardial Infarction (The Partical Study)

Efficacy And Safty of Heartech® Left Ventricular Partitioning Device In Treating Heart Failure Post Myocardial Infarction (Phase II Clinical Trial: The Partical Study)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 117 (estimated)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Efficacy, Safty, Device

Interventions

Type	Name	Description
DEVICE	percutaneous ventricular restoration using heartech® device	Patients who are confirmed suitability by imaging analysis, receive heartech® left ventricular partitioning device implantation.

Timeline

• Start date: 2020-01-02
• Primary completion: 2021-07-31
• Completion: 2022-07-31
• First posted: 2019-07-31
• Last updated: 2020-01-13

Locations

1 site across 1 country: China