Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT04039256
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04039256
Study Brief:
Protocol Section:
NCT04039256