Status:
UNKNOWN
Phase II Clinical Trial of Percutaneous Ventricular Restoration Using Heartech® Device Preventing Heart Failure Post Myocardial Infarction (The Partical Study)
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Conditions:
Efficacy, Safty, Device
Eligibility:
All Genders
18-80 years
Phase:
NA
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 pr...
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2022
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT04039256
Start Date
January 2 2020
End Date
July 31 2022
Last Update
January 13 2020
Active Locations (1)
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1
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025