UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025995 |
|---|---|
| Receipt number | R000029688 |
| Scientific Title | Inappropriate implantable cardioverter-defibrillator therapy: Frequency, syncope and prognostic factors |
| Date of disclosure of the study information | 2017/02/04 |
| Last modified on | 2017/01/25 07:50:19 |
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Basic information
Public title
Inappropriate implantable cardioverter-defibrillator therapy:
Frequency, syncope and prognostic factors
Acronym
Inappropriate ICD therapy survey
Scientific Title
Inappropriate implantable cardioverter-defibrillator therapy:
Frequency, syncope and prognostic factors
Scientific Title:Acronym
Inappropriate ICD therapy survey
Region
| Japan |
Condition
Condition
Life-threatening arrhythmia
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the incidence of syncope related to inappropriate ICD therapies.
Basic objectives2
Others
Basic objectives -Others
To clarify the prognostic factors in patients who had inappropriate ICD therapies.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The incidence of syncope related to inappropriate ICD therapies.
Key secondary outcomes
The prognostic factors in patients who had inappropriate ICD therapies.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
To be enrolled, patients had to: (1) have an indication for ICD or CRT-D implantation according to the JCS Guidelines for Device-based Therapy of Cardiac Rhythm Abnormalities (2) be able to visit scheduled outpatient department and (3) be able to comply with the study protocol.
Key exclusion criteria
Patient exclusion criteria were no information on the medical condition, refused enrollment of this study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiichi Watanabe |
Organization
Fujita Health University School of Medicine
Division name
Department of Cardiology
Zip code
Address
1-98 Dengakugakubo, Kutsukake-cho,Toyoake, Aichi 470-1192
TEL
0562-93-2312
enwatan@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eiichi Watanabe |
Organization
Fujita Health University School of Medicine
Division name
Department of Cardiology
Zip code
Address
1-98 Dengakugakubo, Kutsukake-cho,Toyoake, Aichi 470-1192
TEL
0562-93-2312
Homepage URL
enwatan@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University School of Medicine
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
| 2017 | Year | 02 | Month | 04 | 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
| 2014 | Year | 10 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We examined 772 inappropriate ICD therapies occurring in 417 patients (age 61+/-15 years, primary prevention 65%). Patients experiencing an inappropriate therapy had a mean number of 1.8+/-1.5 therapy episodes during the mean follow-up period of 5.2 years. Only 3 patients (0.7%) experienced syncope associated with inappropriate therapies.
Management information
Registered date
| 2017 | Year | 02 | Month | 03 | Day |
Last modified on
| 2017 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029688
