Nihonbashi Life Science Building 3, 8th floor, 3-8-8, Nihonbashihoncho, Chuo-ku, Tokyo
+81-52-784-6075
aki-i@icornet.jp
Recruiting
Jan. 27, 2026
8
Interventional
single arm study
open(masking not used)
uncontrolled control
single assignment
treatment purpose
1) Patients who sign the consent form of participating clinical study by their free will
2) Patients whose age are 18 years old or more, and 80 years or less at the time of obtaining informed consent
3) Patients whose heart failure symptoms persist despite receiving oral medication in accordance with the guidelines for the treatment of heart failure for more than three months at the time of consent, and whose symptoms are not expected to improve with the current treatment
4) Patients whom NYHA classification is IIm, III or IV A, or level of INTERMACS Profile is 4 to 7
5) Patients with LVEDD more than 60 mm or LVEDDi more than 30 mm/m2 in echocardiography
6) Patients with LVEF less than 40% (MR II or less) or LVEF 45% or less (MR III or more) in echocardiography
7)Patients who can undergo cardiac MRI or contrast-enhanced cardiac CT and cardiac catheterization to manufacture clinical trial equipment
8) Patients who have the intention of follow-up examination and observation, and can be admitted to visit the hospital which carries out them
1) Patients with excessively enlarged heart. LVEDD is more than 100 mm in echocardiography
2) Patients with extremely low LVEF less than 15% in echocardiography
3) Patients who are scheduled for other combined cardiac surgery like mitral valve replacement, mitral valve formation, tricuspid valve formation
4) Patients with history of cardiac surgery except patients with pericardial effusion and mild adhesions
around the heart or patients 3 months after pacemaker treatment with intravenous leads (ICD, CRT-P, CRT-D).
5)Patients undergoing treatment with other cardiac treatment devices such as IABP and ECMO or planning other cardiac surgery
6) Patients who have developed acute myocardial infarction, unstable angina within 3 months or patients
who have undergone PCI or transmyocardial laser revascularization or their candidate patients
7)Patients who required hospitalization for heart failure within one month prior to obtaining consent
8)Patients with NYHA classification IV and who are in heart transplant waiting list
9)Patients with dilated phase hypertrophic cardiomyopathy
10)Patient with active infection
11) Patients with history of cerebrovascular disease within 3 months of obtaining consent
12) Patients with blood clotting disorders or patients who refuse blood transfusion
13) Patients with poor prognosis by malignant diseases
14) Patients with severe dementia, drug addiction, alcoholism
15)Patients with severe allergy
16) Pregnant or nursing patients. Patients who do not agree with contraception during the study
17) Patients participating in other interventional studies
18) Patients whom the investigator determine unsuitable for participation
18age old over
80age old under
Both
dilated cardiomyopathy
Patient-specific cardiac support net is attached to patient's hrart with dilated cardiomyopathy under general anesthesia.
- Adverse events, malfunctions of investigational equipment
- Cardiac function improvement evaluation and prevention of left ventricle remodeling evaluation
- Exercise tolerance : Peak VO2
- Heart-related events during 1 year after implantation of this device
iCorNet Laboratory
Tokyo Women's Medical University Institutional Review Board
