UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical trial for the practical use of a metalic connector for assisted circulation system
Title of the study (Brief title)	Clinical trial for the practical use of a metalic connector for assisted circulation system
Region	Japan

Condition
Condition	Severe heart failure
Classification by specialty	Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study is to evaluate that a new metalic connector could decrease the incidence of thromboembolic events in patients with severe heart failure treated with percutaneous cardio-pulmonary support or extracorporeal ventricular assist device support.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	The frequency of exchange of support device accompanied with thrombosis in the connector. The incidence of thromboembolic events
Key secondary outcomes	30-day mortality frequency of adverse event (hemorrhagic complications) renal function (Creatinine) liver functin (AST, ALT and LDH)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Using a new metalic connector in patinets with severe heart failure treated with circulatory support system
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	7 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	patients with severe heart failure treated with percutaneous cardio-pulumonary support or extracorporeal vantricular assist device support
Key exclusion criteria	Exclusion criteria are as folows. patients with irrecoverable renal failure patients with irrecoverable liver failure patients with respiratory failure without heart failure patinets with severe bleeding tedency small sized child patients patients with allergy to metal
Target sample size	10

Research contact person
Name of lead principal investigator	Shunsuke Kawamoto
Organization	Tohoku University hospital
Division name	Cardiovascular Surgery
Address	1-1, Seiryo-machi, Aoba-ku, Sendai, MIyagi, Japan
TEL	022-717-7222
Email	shunsukekawamoto@med.tohoku.ac.jp

Public contact
Name of contact person	Shunsuke Kawamoto
Organization	Tohoku University hospital
Division name	Cardiovascular Surgery
Address	1-1, Seiryo-machi, Aoba-ku, Sendai, MIyagi, Japan
TEL	022-717-7222
Homepage URL
Email	shunsukekawamoto@med.tohoku.ac.jp

Sponsor
Institute	Tohoku University Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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	東北大学病院（宮城県） Tohoku University Hospital (Miyagi prefecture)

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 23 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 10 Month 19 Day
Anticipated trial start date	2016 Year 10 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 05 Month 17 Day
Last modified on	2019 Year 02 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025747