UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062556 |
|---|---|
| Receipt number | R000071607 |
| Scientific Title | The Japan Surgical Unloading Renal Protection and Sustainable Support Study (SURPASS JP) |
| Date of disclosure of the study information | 2026/08/12 |
| Last modified on | 2026/08/12 03:24:47 |
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Basic information
Public title
The Japan Surgical Unloading Renal Protection and Sustainable Support Study (SURPASS JP)
Acronym
SURPASS JP
Scientific Title
The Japan Surgical Unloading Renal Protection and Sustainable Support Study (SURPASS JP)
Scientific Title:Acronym
SURPASS JP
Region
| Japan |
Condition
Condition
Patients who receive Impella 5.5 support as standard of care
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To document quality performance measures assessing the post-market surgical performance and clinical management of patients supported with Impella 5.5, and to identify factors influencing treatment strategies for Impella 5.5
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Outcomes at discharge (heart transplant, durable left ventricular assist device, native heart survival) and survival to 1-, 6-, and 12-months following index hospital discharge
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patient underwent placement of an Impella 5.5 device and received Impella 5.5 support at a participating study site
2. >= 18 years of age
Key exclusion criteria
1. Informed consent was not obtained during the index hospitalization
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Toda |
Organization
Dokkyo Medical University Saitama Medical Center
Division name
Cardiac Surgery
Zip code
Saitama 343-8555
Address
Koshigaya Minami Koshigaya 2-1-50, Saitama 343-8555, Japan
TEL
0489650658
k-toda@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Poornima |
| Middle name | |
| Last name | Sood |
Organization
ABIOMED, Inc.
Division name
Global Clinical Affairs
Zip code
01923
Address
22 Cherry Hill Drive, Danvers, MA 01923, USA
TEL
9786461400
Homepage URL
PSood4@its.jnj.com
Sponsor or person
Institute
ABIOMED, Inc. (Sponsor)
Institute
Department
Personal name
Funding Source
Organization
ABIOMED, Inc. (Sponsor)
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NPO MINS
Address
5-20-9-401 Mita, Minato-ku, Tokyo, Japan
Tel
0364161868
npo-mins@j-irb.com
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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 12 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2026 | Year | 08 | Month | 12 | Day |
Last modified on
| 2026 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071607
