UMIN-CTR Clinical Trial

Public title

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

Acronym

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

Scientific Title

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

Scientific Title:Acronym

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

Region

Japan

Condition

Dilated cardiomyopathy

Classification by specialty

Cardiovascular surgery

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the safeness of Patient-Specific Cardiac Support Net to prevent the progression of left ventricular remodeling in dilated cardiomyopathy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

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

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Cardiac Support Net

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

20

years-old

<=

Age-upper limit

75

years-old

>=

Gender

Male and Female

Key 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 (ACEI, ARB, diuretics, beta-blockers,oral cardiotonic, etc.) 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 >= 60mm or LVEDDi >= 30mm/m² in echocardiography
6) Patients with LVEF <= 35% in echocardiography
7) Patients with RVEDVi <= 170mL/m² by MRI or CT analysis
8) Patients with walking distance of 6 minutes <= 450m
9) Patients who have the intention of follow-up examination and observation, and can be admitted to visit the hospital which carries out them

Key exclusion criteria

1)Patients with excessively enlarged heart(LVEDD>85mm)
2)Patients with extremely low LVEF(<10%)
3)Patients with history of cardiac surgeryexcept 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 (FEV-1 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 (cerebral infarction, cerebral hemorrhage, etc.) within 3 months
20)Patients with a high degree of bleeding tendency
21)Patients with blood clotting disorders (patients with contraindicated for antithrombotic treatment)
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

Target sample size

8

Name of lead principal investigator

1st name
Middle name
Last name	Toshiaki Akita

Organization

Nagoya University School of Medicine

Division name

Cardiac Surgery

Zip code

Address

65 Tsurumai-cho, Showa-ku, Nagoya, Aichi

TEL

052-744-2376

Email

takita@med.nagoya-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Toshiaki Akita

Organization

Nagoya University School of Medicine

Division name

Cardiac Surgery

Zip code

Address

65 Tsurumai-cho, Showa-ku, Nagoya, Aichi

TEL

052-744-2376

Homepage URL

Email

takita@med.nagoya-u.ac.jp

Institute

Nagoya University School of Medicine

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Osaka University Hospital, Tohoku University Hospital, Jikei University,Nagago unversity

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

大阪大学医学部附属病院(大阪府)、東北大学医学部附属病院(宮城県)、東京慈恵会医科大学附属病院(東京）、

Date of disclosure of the study information

2015

Year

10

Month

05

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

Terminated

Date of protocol fixation

2015

Year

06

Month

10

Day

Date of IRB

Anticipated trial start date

2015

Year

10

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

10

Month

05

Day

Last modified on

2019

Year

03

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022142