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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007155
Receipt No. 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

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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
Email 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
Email toshihiro.matsumoto@medtronic.com

Sponsor
Institute Medtronic Japan CO., Ltd
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008308

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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