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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008773
Receipt No. R000010309
Scientific Title Detection of Ventricular Fibrillation via the Left Ventricular Lead Implanted for Resynchronization Therapy
Date of disclosure of the study information 2012/08/31
Last modified on 2019/02/18

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Basic information
Public title Detection of Ventricular Fibrillation via the Left Ventricular Lead Implanted for Resynchronization Therapy
Acronym Detection of Ventricular Fibrillation via the Left Ventricular Lead
Scientific Title Detection of Ventricular Fibrillation via the Left Ventricular Lead Implanted for Resynchronization Therapy
Scientific Title:Acronym Detection of Ventricular Fibrillation via the Left Ventricular Lead
Region
Japan

Condition
Condition chronic heart failure, ventricular fibrillation
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate equivalence in detection of ventricular fibrillation on implantable cardioveter defibrillator between the left ventricular lead and the right ventricular lead
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes equivalece in detection of ventricular fibrillation between the left ventricular lead and the right ventricular lead
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 recording of the intracardiac electrocardiogram via the left ventricular lead at the defibrillation test
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. All subjects must give the agreement for implantation or replacement of implantable resynchronization therapy defibrillator in writing.

Key exclusion criteria 1.patients who cannot give the informed consent.
2.patients who do not fit the clinical indication for defibrillation test.
3. patients who are implanted with the unipolar left ventricular lead or more suitable for the unipolar LV lead than the bipolar LV lead.
4.patients implanted with a CRTD
using significantly different filter for VF detection from that of a test ICD or a new CRTD.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshio Kobayashi
Organization Chiba University Graduate School of Medicine
Division name Department of Cardiovascular Science and Medicine
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba, Chiba 260&#8211;8670, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Marehiko Ueda
Organization Chiba University Hospital
Division name Department of Cardiology
Zip code
Address
TEL
Homepage URL
Email zta10540@nifty.com

Sponsor
Institute Chiba University Graduate School of Medicine
Department of Cardiovascular Science and Medicine
Institute
Department

Funding Source
Organization any organizations do not give specific fund for this study
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
Address
Tel
Email

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
2012 Year 08 Month 31 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 Completed
Date of protocol fixation
2012 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 08 Month 26 Day
Last modified on
2019 Year 02 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010309

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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