UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057768 |
|---|---|
| Receipt number | R000065750 |
| Scientific Title | Transcatheter versus conservative strategies for severe mitral regurgitation requiring Impella support |
| Date of disclosure of the study information | 2025/05/03 |
| Last modified on | 2025/12/18 06:07:46 |
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Basic information
Public title
The Transcatheter strategy for severe mitral regurgitation requiring percutaneous ventricular assist device support study
Acronym
TREAT MR study
Scientific Title
Transcatheter versus conservative strategies for severe mitral regurgitation requiring Impella support
Scientific Title:Acronym
Treatment strategies with Impella for MR
Region
| Japan |
Condition
Condition
Isolated severe MR complicated by either drug-refractory heart failure or cardiogenic shock requiring Impella support
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study sought to evaluate the short-term clinical outcomes of transcatheter strategy for severe MR requiring Impella support for hemodynamic stabilization, using a nationwide registry of all Impella-treated patients in Japan.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome was in-hospital mortality.
Key secondary outcomes
Secondary outcomes were in-hospital events, including cardiac death, stroke, cardiac tamponade, acute kidney injury, sepsis, severe bleeding, limb ischemia, and ventricular tachycardia or fibrillation.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with severe MR complicated by drug-refractory heart failure or cardiogenic shock requiring Impella support
Key exclusion criteria
Patients who required therapeutic interventions other than for the mitral valve
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Isawa |
Organization
Sendai Kousei Hospital
Division name
Cardiology Department
Zip code
981-0914
Address
1-20, Tsutsumidouri-amamiya, Sendai, Japan
TEL
022-728-8000
isa_tsuyo@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Isawa |
Organization
Sendai Kousei Hospital
Division name
Cardiology Department
Zip code
981-0914
Address
1-20, Tsutsumidouri-amamiya, Sendai, Japan
TEL
022-728-8000
Homepage URL
isa_tsuyo@yahoo.co.jp
Sponsor or person
Institute
Sendai Kousei Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sendai Kousei Hospital
Address
1-20, Tsutsumidouri-amamiya, Sendai, Japan
Tel
0227288000
isa.tsuyo@gmail.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
| 2025 | Year | 05 | Month | 03 | 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
82
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective cohort study
Management information
Registered date
| 2025 | Year | 05 | Month | 03 | Day |
Last modified on
| 2025 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065750
