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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000043872
Receipt No. 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 2021/04/08

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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
Email 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
Email m.watanabe@huhp.hokudai.ac.jp

Sponsor
Institute Hokkaido University
Institute
Department

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
Email 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
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 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
2021 Year 04 Month 06 Day
Last follow-up date
2024 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
2021 Year 04 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050085

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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