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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001387
Receipt No. R000001682
Scientific Title Clinical trial on left heart assist system TRE-689
Date of disclosure of the study information 2008/09/22
Last modified on 2011/03/22

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Basic information
Public title Clinical trial on left heart assist system TRE-689
Acronym Clinical trial on left heart assist system TRE-689
Scientific Title Clinical trial on left heart assist system TRE-689
Scientific Title:Acronym Clinical trial on left heart assist system TRE-689
Region
Japan

Condition
Condition End Stage Heart Failure
Classification by specialty
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aims of this trial are to evaluate the safety and effectiveness of TRE-689 from the viewpoint of implantation, postoperative management and home care in patients with end stage heart failure in Japan.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 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)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Implantation of TRE-689
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
15 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key 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
Key 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.
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nishimura Motonobu
Organization Tottori University
Division name Faculty of Medicine
Zip code
Address 36-1 Nishimachi, Yonago Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Terumo Corporation
Division name Clinical Development Department
Zip code
Address 1500 Inokuchi, Nakai-machi, Ashigarakami-gun, Kanagawa, Japan
TEL
Homepage URL
Email

Sponsor
Institute Terumo Corporation
Institute
Department

Funding Source
Organization Terumo Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2008 Year 09 Month 22 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2008 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 10 Month 01 Day
Last follow-up date
2009 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 09 Month 22 Day
Last modified on
2011 Year 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001682

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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