UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007155 |
|---|---|
| Receipt number | R000008308 |
| Scientific Title | The validation of QRS morphology with wavelet |
| Date of disclosure of the study information | 2012/02/01 |
| Last modified on | 2016/01/28 14:55:29 |
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Basic information
Public title
The validation of QRS morphology with wavelet
Acronym
Wavelet study
Scientific Title
The validation of QRS morphology with wavelet
Scientific Title:Acronym
Wavelet study
Region
| Japan |
Condition
Condition
Life-threatening arrhythmia and serious heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the wavelet study is to evaluate of QRS morphology with both 12 lead ECG and wavelet feature on Medtronic ICD and CRTD device for patients with life threatening arrhythmia and serious heart failure. We will focus on the transformation of QRS morphology when patients' heart rate rises.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluate the transformation of QRS morphology with both 12 lead ECG and the wavelet in each heart rate
Key secondary outcomes
Evaluate the transformation of QRS morphology with both 12 lead ECG and the wavelet after shock therapy
Review incidence of arrhythmia and transformation of QRS morphology in each heart rate.
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
| 20 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients implanted a ICD/CRT-D device incorporated wavelet function in study centers
Ptients adapted atrial pacing
Patients willing to provide written informed consent
Key exclusion criteria
Patients unadapted the wavelet function
Patients with advanced atrioventricular block
Patients with permanent atrial fibrillation
Patients younger than 20 years
Patients unwilling to provide written informed consent
Patients with any situation that preclude the testing required for all subjects or that otherwise limit study participation required for all subjects (e.g. life expectancy, mental disorder)
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiko Takagi, MD |
Organization
Osaka City University Hospital
Division name
Department of Internal Medicine and Cardiology
Zip code
Address
1-5-7, Asahimachi, Abeno-ku, Osaka city, Osaka, 545-8586 Japan
TEL
06-6645-2121
m7424580@msic.med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshihiro Matsumoto |
Organization
Medtronic Japan CO., Ltd
Division name
CRDM
Zip code
Address
7-1-16 Minatominamimachi, Chuo-ku, Kobe-city, Hyogo
TEL
078-306-2881
Homepage URL
toshihiro.matsumoto@medtronic.com
Sponsor or person
Institute
Medtronic Japan CO., Ltd
Institute
Department
Personal name
Funding Source
Organization
Medtronic Japan CO., Ltd
Organization
Division
Category of Funding Organization
Profit organization
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 | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2011 | Year | 11 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | 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
Prospective, multicenter study
Management information
Registered date
| 2012 | Year | 01 | Month | 27 | Day |
Last modified on
| 2016 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008308
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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