JPRN-jRCT2042210157
Recruiting
Phase 2
Investigator-initiated clinical trial of Patient-Specific Cardiac Support Net for dilated cardiomyopathy
Akita Toshiaki0 sites5 target enrollmentMarch 6, 2022
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- dilated cardiomyopathy
- Sponsor
- Akita Toshiaki
- Enrollment
- 5
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion 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
Exclusion 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
Outcomes
Primary Outcomes
Not specified
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