UMIN-CTR Clinical Trial

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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