UMIN-CTR Clinical Trial

Basic information
Public title	Single-arm study for assessment of safety and effectiveness of the ultracompact extracorporeal membrane oxygenation (ECMO) system (BR13030) use as a long-term cardiopulmonary support for severe heart and/or respiratory failure: study protocol for multiple-center, single-arm non-randomized, uncontrolled, and investigator-initiated clinical trial
Acronym	NCVC-ECMO_01
Scientific Title	Single-arm study for assessment of safety and effectiveness of the ultracompact extracorporeal membrane oxygenation (ECMO) system (BR13030) use as a long-term cardiopulmonary support for severe heart and/or respiratory failure: study protocol for multiple-center, single-arm non-randomized, uncontrolled, and investigator-initiated clinical trial.
Scientific Title:Acronym	Single-arm study for assessment of safety and effectiveness of the ultracompact extracorporeal membrane oxygenation (ECMO) system (BR13030) use as a long-term cardiopulmonary support for severe heart and/or respiratory failure: study protocol for multiple-center, single-arm non-randomized, uncontrolled, and investigator-initiated clinical trial.
Region	Japan

Condition
Condition	Subjects with severe heart failure or cardiogenic shock refractory to optimal medical management, standard surgical procedures, or mechanical circulatory supports [e.g. intra-aortic balloon pumping (IABP), ventriculo-arterial bypass (VA bypass) and percutaneous cardiopulmonary support (PCPS)) etc.] and severe respiratory failure refractory to optimal medical management, standard surgical procedure including lung transplantation, volume reduction surgery etc., oxygen therapy, physical therapy and mechanical ventilator
Classification by specialty	Cardiology Pneumology Cardiovascular surgery Emergency medicine Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Single-arm study for assessment of safety and effectiveness of the ultracompact extracorporeal membrane oxygenation (ECMO) system (BR13030) use as a long-term cardiopulmonary support for severe heart and/or respiratory failure: study protocol for multiple-center, single-arm non-randomized, uncontrolled, and investigator-initiated clinical trial.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase III

Assessment
Primary outcomes	Safety: Device-related serious adverse events and complications during device support Effectiveness: Cardiac and/or respiratory function recovery during 14 days after implantation of a trial device
Key secondary outcomes	Common secondary outcomes 1)Total support period of a trial device 2)Removal of mechanical ventilation during device support and interval between implantation and withdrawal of a trial device 3)Device-unrelated death All death during device support (max. 14 days) 4)Suspiciously dDevice-related death between implantation and 7days after withdrawal of a trial device 5)Adverse events and device failure Outcomes of VA ECMO 1)Changes in brain natriuretic peptide (BNP) levels (7 days after implantation and the day of withdrawal of a trial device) 2)Changes in left ventricular ejection fraction (LVEF)(7 days after implantation and the day of withdrawal of a trial device) 3)Changes in left ventricular diastolic dimension (LVDd)(7 days after implantation and the day of withdrawal of a trial device) Outcomes of VV ECMO 1)Arterial oxygen and carbon dioxide partial pressure (PaO2 and PaCO2)(7 days after implantation and the day of withdrawal of a trial device)

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	The ultracompact extracorporeal membrane oxygenation (ECMO) system (BR13030) is implanted within 3 days after study entry. BR13030 is withdrawn during 14 days after implantation of a trial device. BR13030 can be converted to a new BR13030, if required medically. The patients are observed for safety during 7 days after withdrawal of the last implanted BR13030.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Serious heart failure or refractory cardiogenic shock due to the following diseases, which does not respond to optimal medication and mechanical support a.Underlying disorders causing serious heart failure or refractory cardiogenic shock 1.low cardiac output syndrome due to cardiac disorders (idiopathic, secondary or ischemic cardiomyopathy, or myocarditis) 2.post-acute myocardial infarction circulatory failures (including mechanic complication or refractory arrhythmia) 3. difficulty in withdrawal of cardiopulmonary bypass 4. postoperative low cardiac output syndrome (including refractory arrhythmia) 5. other cardiogenic circulatory failures (including refractory arrhythmia) b. Underlying disorders causing severe respiratory failure 1.severe infectious (viral or bacterial) and aspiration pneumonia 2.acute respiratory distress syndrome (ARDS) 3.bridge to lung transplantation, primary lung graft failure such as reperfusion injury 4.difficulty in withdrawal of cardiopulmonary support due to respiratory failure 5.transient respiratory failure in patients with chronic lung disease 6.heavy asthma attack 7.other acute respiratory failures 2) Body weight not lower than 10kg at the time of informed consent 3) Written informed consent of the patient or his/her relatives
Key exclusion criteria	1) Unfavorable or technically-challenging cardiac anatomy 2) Evidence of irreversible hepatic disease (except when the primary investigator deems it as a sign of acute heart failure) 3) Evidence of irreversible renal disease (except when the primary investigator deems it as a sign of acute heart failure) 4) Contraindicated for anticoagulation 5) Difficulty of 14-day observation is anticipated 6) Participating in another clinical trial at time of study entry 7) Deemed unsuitable by the primary investigator for other reasons
Target sample size	25

Research contact person
Name of lead principal investigator	1st name Norihide Middle name Last name Fukushima
Organization	National Cerebral and Cardiovascular Center
Division name	Department of Transplant Medicine
Zip code	564-8565
Address	6-1 Kishibe-Shinmachi, SUita, Osaka
TEL	0661701070
Email	nori@ncvc.go.jp

Public contact
Name of contact person	1st name Takuya Middle name Last name Watanabe
Organization	National Cerebral and Cardiovascular Center
Division name	Department of Transplant Medicine
Zip code	564-8565
Address	6-1 Kishibe-Shinmachi, Suita, Osaka
TEL	06-6170-1070
Homepage URL
Email	watanabe.takuya@ncvc.go.jp

Sponsor
Institute	National Cerebral and Cardiovascular Center
Institute
Department

Funding Source
Organization	Nipro Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	National Cerebral and Cardiovascular Center
Address	6-1 Kishibe-Shinmachi, Suita, Osaka
Tel	0666170-1070
Email	nori@ncvc.go.jp

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	大阪大学病院（大阪府）、関西医科大学総合医療センター（大阪府）

Other administrative information
Date of disclosure of the study information	2020 Year 02 Month 17 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	Completed
Date of protocol fixation	2020 Year 02 Month 10 Day
Date of IRB	2019 Year 12 Month 23 Day
Anticipated trial start date	2020 Year 02 Month 10 Day
Last follow-up date	2021 Year 12 Month 17 Day
Date of closure to data entry	2022 Year 03 Month 09 Day
Date trial data considered complete	2022 Year 04 Month 01 Day
Date analysis concluded	2022 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date	2020 Year 02 Month 13 Day
Last modified on	2022 Year 01 Month 27 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045004