UMIN-CTR Clinical Trial

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

End Stage Heart Failure

Classification by specialty

Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Terumo Corporation

Institute

Department

Personal name

Organization

Terumo Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2008

Year

09

Month

22

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2008

Year

09

Month

22

Day

Last modified on

2011

Year

03

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001682