UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008773 |
|---|---|
| Receipt number | 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 21:27:19 |
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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 260–8670, Japan
TEL
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
zta10540@nifty.com
Sponsor or person
Institute
Chiba University Graduate School of Medicine
Department of Cardiovascular Science and Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010309
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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