Investigator-initiated clinical trial of Patient-Specific Cardiac Support Net for dilated cardiomyopathy

JRCT ID: jRCT2042210157

Registered date:06/03/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: dilated cardiomyopathy
• Date of first enrollment: 01/04/2022
• Target sample size: 5
• Study type: Interventional
• Intervention(s): To evaluate the safeness and effectiveness of patient-specific cardiac support net applied to patients with dilated cardiomyopathy under general anesthesia.

Outcome(s)

Primary Outcome

The evaluation of the safeness:
Adverse events and device trouble during 24 weeks after implantation of this device.
The evaluation of the effectiveness:
Exercise tolerance 24 weeks after implantation of this device.

Secondary Outcome

1) Cardiac function improvement evaluation and prevention of left ventricle remodeling evaluation.
2)Exercise tolerance.
3) Heart-related events during 24 weeks after implantation of this device.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

1) Patients who sign the consent form of participating clinical study by their free will
2) Patients whose age are 20 years old or more, and 75 years or less at the time of obtaining informed consent
3) Patients with heart failure symptoms in spite of optimal drug oral treatment for heart failure of more than 3 months at the time of obtaining informed consent
4) Patients whom NYHA classification is IIm, III or IV, 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 35% in echocardiography
7)Patients with Peak VO2 between 7 to 16 mL/kg/min in cardiopulmonary exercise testing .
8) Patients who can undergo cardiac MRI or contrast-enhanced cardiac CT and cardiac catheterization to manufacture clinical trial equipment
9) Patients who have the intention of follow-up examination and observation, and can be admitted to visit the hospital which carries out them

Exclude criteria

1) Patients with excessively enlarged heart. LVEDD is more than 90 mm in echocardiography
2) Patients with extremely low LVEF less than 10% 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 with NYHA classification IV and who are adapted to left ventricular assist devices or candidate
for heart transplant
8) Patients with dilated phase hypertrophic cardiomyopathy
9) Patient with active infection
10) Patients with history of cerebrovascular disease within 3 months of obtaining consent
11) Patients with blood clotting disorders or patients who refuse blood transfusion
12) Patients with poor prognosis by malignant diseases
13) Patients with severe dementia, drug addiction, alcoholism
14)Patients with severe allergy
15) Pregnant or nursing patients. Patients who do not agree with contraception during the study
16) Patients participating in other interventional studies
17) Patients whom the investigator determine unsuitable for participation

Related Information

• Primary Sponsor: Akita Toshiaki
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development