End Stage Heart Failure
Conditions
Interventions
Implantation of TRE-689
Sponsors
Terumo Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients satisfying all of the below-shown requirements. Requirements 2)through 7)need to be satisfied at the time of registration. 1)Age between 15 and 65 at the time of informed consent 2)Patients with irreversible terminal stage severe heart failure indicated for heart transplantation: The following patients are rated as "indicated for heart transplantation": a)Diseases indicated: The below-shown cases of severe heart failure were saving the life or prolonging the survival period is not expected with conventional methods of treatment: -Dilated cardiomyopathy and hypertrophic cardiomyopathty at diastole -Ischemic heart disease -Others(heart diseases specified by the Heart Transplantation Committee of the Japanese Circulation Society and the Japanese Society of Pediatric Cardiology and Cardiac Surgery) b)Criteria: Cases of incurable terminal condition, satisfying at least one of the following requirements: -Patients requiring long-term or repeated hospital stay because of heart failure -Patients remaining at NYHA heart function class III or IV despite treatment with conventional drugs(including beta-blockers or ACE inhibitors)or having a history of class IV -Patients with fatal severe arrhythmias not responding to any conventional therapy 3)Patients depending on medical treatment using cardiotonics(dobutamine, dopamine, milrinone, etc.)or mechanical assist of circulation(intraaortic balloon pumping(IABP), extracorporeal artificial heart, etc 4)Patients with body surface area between 1.4 and 2.5 m2 5)Patients who can receive adequate supports from family members, blood relatives or the like 6)Patients who can receive blood transfusion 7)Patients who can understand the study and can issue consent to the study in writing(or consent issued by proxy consenter). If the patient is a minor, consent is needed from both the patient and the proxy consenter 8)Patients who can be followed continuously after having given consent to the study
Exclusion criteria
Exclusion criteria: Patients falling under any of the following criteria at the time of registration are excluded from this study: (1)Patients with severely compromised function of the right half of the heart system; (2)Patients with moderate or severer aortic valve insufficiency or with a prosthetic aortic valve; (3)Patients with severe calcification of the ascending or descending thoracic aorta; (4)Patients with severe infection, testing positively in blood culture or showing elevated body temperature (over 38oC); (5)Patients with irreversible failure of any other than the heart; (6)Patients with severe chronic obstructive pulmonary disease; (7)Patients having developed marked pulmonary artery embolism within 30 days before registration; (8)Patients with severe pulmonary hypertension; (9)Patients with gastrointestinal inflammation, severe hypertension, severe diabetes mellitus or the like; (10)Patients having developed myocardial infarction within 30 days before registration; (11)Patients having received open heart surgery very recently (within 2 weeks before registration); (12)Patients with severe disorders of the central nervous system; (13)Patients with severe cerebrovascular disease; (14)Patients complicated by malignant disease with poor prognosis; (15)Markedly obese patients; (16)Patients complicated by systemic disease (collagen disease, etc.); (17)Patients with a history of neuropsychiatric disease severe enough to make it impossible to follow or understand the protocol; (18)Pregnant or possibly pregnant patients; (19)Patients with a history of heparin-induced thrombopenia or with severe hematological disorders (hemorrhagic tendency, clotting disorder, etc.); (20)Patients with a history of drug or alcohol addiction; (21)Patients having completed any other clinical trial within 6 months before registration; (22)Patients rated by the investigator or sub-investigator as inappropriate for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Efficacy endpoints (1)Success or failure of implantation (2)Survival or death of patient (3)QOL and NYHA cardiac function class (4)Pump function (5)Duration of assisted circulation (in days) 2.Safety endpoints (1)Time course of indicators of blood coagulation (2)Breakage or malfunction of the device (3)Adverse event and Device-related Adverse event (4)Major and serious adverse events (5)Time course of vital signs, laboratory parameters (hematology, BNP and biochemistry) and psychiatric test data (depression scale and emotional disorder scale) | — |
Countries
Japan
Outcome results
None listed