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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000019236
Receipt No. R000022142
Scientific Title Clinical study of Patient-Specific Cardiac Support Net for dilated cardiomyopathy.
Date of disclosure of the study information 2015/10/05
Last modified on 2019/03/08

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Basic information
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
Condition Dilated cardiomyopathy
Classification by specialty
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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

Base
Study type Interventional

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

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Nagoya University School of Medicine
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Osaka University Hospital, Tohoku University Hospital, Jikei University,Nagago unversity
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 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)、

Other administrative information
Date of disclosure of the study information
2015 Year 10 Month 05 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 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
Other related information

Management information
Registered date
2015 Year 10 Month 05 Day
Last modified on
2019 Year 03 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022142

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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