Clinical study of Patient-Specific Cardiac Support Net for dilated cardiomyopathy

JRCT ID: jRCTs042180025

Registered date:15/01/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: dilated cardiomyopathy
• Date of first enrollment: 15/01/2019
• Target sample size: 3
• 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 and med-line sternotomy.

Outcome(s)

Primary Outcome

The evaluation of the safeness during 24 weeks after implantation of this device.
1) New treatment added by heart failure exacerbation, and another performing of cardiac surgery.
2) All-cause mortality, cardiac death. (death due to heart failure exacerbation)
3) all adverse events.
4) Device trouble.

Secondary Outcome

Secondary End Point; The evaluation of the effectiveness during 24 weeks after implantation of this device.
1) Prevention of left ventricle remodeling evaluation
2) Cardiac function improvement evaluation
3) Subjective symptoms, QOL evaluation

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
4) Patients whom NYHA classification is 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 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 85 mm
2. Patients with extremely low LVEF less than 10%
3. Patients with history of cardiac surgery except pacemaker implantation.
4. Patients who are scheduled for other cardiac surgery
5. Patients with the history or the schedule of CABG
6. Patients with the history or candidate of PCI or trans myocardial laser revascularization within 3 months
7. Patients who are implementing the IABP
8. Patients who are adapted to left ventricular assist devices or scheduled heart transplant
9. Patients with the history or schedule for ICD & CRT within 3 months
10. Patients whose life expectancy 1 year or less
11. Heart failure patients in end stage whose surgery risk is unacceptably high
12. Patients who have developed acute myocardial infarction, unstable angina within 3 months
13. Patients with hypertrophic cardiomyopathy
14. Patient with active infection
15. Patients with severe liver dysfunction whose AST or ALT values are more than 5 times of normal range in their institute.
16. Patients with poor lung function. FEV1 is less than 50%
17. Patients with severe renal failure. Serum creatinine is 3 mg/dL or more or patients with dialysis-dependent
18. Patients with diffuse peripheral vascular disease
19. Patients with history of cerebrovascular disease within 3 months
20. Patients with a high degree of bleeding tendency
21. Patients with blood clotting disorders
22. Patients who refuse blood transfusion
23. Patients with poor prognosis by malignant diseases
24. Patients with severe dementia, drug addiction, alcoholism
25. Patients with severe allergy
26. Pregnant or nursing patients. Patients who do not agree with contraception during the study
27. Patients participating in other studies
28. Patients whom the investigator determine unsuitable for participation

Related Information

• Primary Sponsor: Mutsuga Masato
• Source(s) of Monetary Support: Terumo Foundation for Life Science and Arts