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

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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name