UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043872 |
|---|---|
| Receipt number | R000050085 |
| Scientific Title | Risk Factors and Prognostic Outcomes for Ventricular Arrhythmia in Patients with Left Ventricular Assist Device |
| Date of disclosure of the study information | 2021/04/08 |
| Last modified on | 2023/04/11 10:12:31 |
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Basic information
Public title
Risk Factors and Prognostic Outcomes for Ventricular Arrhythmia in Patients with Left Ventricular Assist Device
Acronym
Risk Factors and Prognostic Outcomes for Ventricular Arrhythmia in Patients with Left Ventricular Assist Device
Scientific Title
Risk Factors and Prognostic Outcomes for Ventricular Arrhythmia in Patients with Left Ventricular Assist Device
Scientific Title:Acronym
Risk Factors and Prognostic Outcomes for Ventricular Arrhythmia in Patients with Left Ventricular Assist Device
Region
| Japan |
Condition
Condition
Ventricular tachycardia
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the impact for cardiac event and risk factor of ventricular arrhythmia in patients with an implantable cardioverter-defibrillator and left ventricular assist device
Basic objectives2
Others
Basic objectives -Others
Prognosis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Composite of cardiac death and admission for cardiovascular disease
Key secondary outcomes
1 Risk of ventricular arrhythmia
2 QOL score, depression score
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
1 Patient with LVAD
2 Patient with an ICD
Key exclusion criteria
none
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masaya |
| Middle name | Watanabe |
| Last name | Watanabe |
Organization
Hokkaido University Hospital
Division name
Department of cardiovascular medicine
Zip code
060-8638
Address
North 15, West 7, Kita-ku, Sapporo city
TEL
011-706-6973
m.watanabe@huhp.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Masaya |
| Middle name | |
| Last name | Watanabe |
Organization
Hokkaido University Hospital
Division name
Department of cardiovascular medicine
Zip code
060-8638
Address
North 15, West 7, Kita-ku, Sapporo city
TEL
011-706-6973
Homepage URL
m.watanabe@huhp.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Medtronic
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University
Address
North 15, West 7, Kita-ku, Sapporo city
Tel
0117066973
m.watanabe@huhp.hokudai.ac.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | Month | 08 | 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
| Delay expected |
Results Delay Reason
Because we have less number of patients enrolled than estimated
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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 31 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We aim to investigate the influence for prognosis and risk of ventricular arrhythmia in patients with LVAD and ICD.
Appropriate ICD indication and better therapeutic approach in this particular patient population will be clear.
Management information
Registered date
| 2021 | Year | 04 | Month | 08 | Day |
Last modified on
| 2023 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050085
