UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002372 |
|---|---|
| Receipt number | R000002875 |
| Scientific Title | Reliability of Implantable Cardioverter-Defibrillator Home Monitoring in Forecasting the Necessity of Regular Office Visit and Patients' Perspectives: Japanese HOME ICD Study |
| Date of disclosure of the study information | 2009/09/01 |
| Last modified on | 2014/06/19 14:36:21 |
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Basic information
Public title
Reliability of Implantable Cardioverter-Defibrillator Home Monitoring in Forecasting the Necessity of Regular Office Visit and Patients' Perspectives: Japanese HOME ICD Study
Acronym
J-HOME ICD
Scientific Title
Reliability of Implantable Cardioverter-Defibrillator Home Monitoring in Forecasting the Necessity of Regular Office Visit and Patients' Perspectives: Japanese HOME ICD Study
Scientific Title:Acronym
J-HOME ICD
Region
| Japan |
Condition
Condition
Tachyarrhythmia and Heart Failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The focus of the J-Home ICD study will be to evaluate the diagnostic power of telemetrically transmitted data from Home Monitoring, with regard to the necessity for patient follow-up. The main goal of this study is to investigate whether it is possible to individualize the follow-up scheduling of ICD/CRT-D patients due to Home Monitoring.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
A PRE Follow-Up assessment based on the Cardio Reports is completed to forecast the necessity of the follow up. This is compared with a POST Follow-Up assessment which is completed after the scheduled follow-up. It is expected that at most 5 % of the decisions are false negative.
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Indicated for ICD or CRT-D implantation under Japanese guidelines.
2.Implanted within the last 10 days (or being considered for implant) with a BIOTRONIK Lumax device.
3.Patients that are geographically stable and are able to attend the follow-up investigations according to the protocol.
4.The patient unerstands the nature of procedure.
5. Patients that have been informed about the investigation, that have read and understood the patient information and have signed the declaration of patient informed consent.
6. The Patient is able to complete all testing required by the clinical investigation plan.
Key exclusion criteria
1. Contraindicated for ICD or CRT-D implantation under Japanese guidelines.
2. Patients who are not able to handle the system correctly.
3. Patients who are currently included in another cardiac clinical study.
4. Patient with life expectancy of less than 12 months.
5. Patient expected to recieve heart implantation within twelve months.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiichi Watanabe |
Organization
Fujita Health University Hospital
Division name
Cardiovascular Internal Medicine
Zip code
Address
Kutsukake-cho, Toyoake-city, Aichi, Japan
TEL
0562-93-2111
enwatan@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ruiko Nakashima |
Organization
Biotronik Japan
Division name
Clinical Fellow
Zip code
Address
1-19-19 Ebisu, Shibuya-ku, Tokyo
TEL
03-3473-7478
Homepage URL
ruiko.nakashima@biotronik.co.jp
Sponsor or person
Institute
Biotronik Japan
Institute
Department
Personal name
Funding Source
Organization
Biotronik Japan
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
三重ハートセンター（三重県）、豊橋ハートセンター（愛知県）、三重大学（三重県）、山田赤十字病院（三重県）、一宮市民病院（愛知県）、岡山大学（岡山県）、済生会下関総合病院（山口県）、松阪中央総合病院（三重県）、済生会熊本病院（熊本県）、昭和大学藤が丘病院（神奈川県）、慶應義塾大学（東京都）、東京都立広尾病院（東京都）、金沢循環器病院（石川県）、秋田県成人病医療センター（秋田県）、総合南東北病院（福島県）、船橋市立医療センター（千葉県）、群馬大学（群馬県）、厚生連高岡病院（富山県）、広島大学（広島県）、東海大学（神奈川県）、名古屋東市民病院（愛知県）、大阪赤十字病院（大阪府）、金沢大学（石川県）、富山県立中央病院（富山県）、名古屋徳洲会総合病院（愛知県）、奈良県立医科大学（奈良県）、聖マリアンナ医科大学（神奈川県）、金沢医科大学（石川県）、岐阜ハートセンター（岐阜県）、九州医療センター（福岡県）、県西部浜松医療センター（静岡県）、名古屋掖済会病院（愛知県）、熊本赤十字病院（熊本県）、静岡市立静岡病院（静岡県）、浜松医科大学（静岡県）、鹿児島医療センター（鹿児島県）、池上総合病院（東京都）、尾道総合病院（広島）名古屋第一赤十字病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/browse/circj/77/11/_contents
Number of participants that the trial has enrolled
Results
Overall, 663 pairs of pre-and post regular follow-up (RFU) assessments were compared. The number of pre-RFU assessments failing to predict the need for RFU was 38 (5.7%), fulfilling the study hypothesis of 5.0 plus minus 4.0% (P<0.002;95% confidence interval: 4.1-7.8%). Judged by an independent committee, the rate of false pre-RFU forecasts with high clinical relevance was 2 (0.3%). RM correctly forecasted non-necessity of 498 scheduled RFUs (75.1%). Patient acceptance or RM was evaluated using a targeted questionnaire. Of 182 interviewed patients, 172 (94.5%) felt security and comfort.
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
| 2009 | Year | 04 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
| 2012 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 09 | Month | 30 | Day |
Other
Other related information
Compare Home Monitoring system and out patient follow-up.
Management information
Registered date
| 2009 | Year | 08 | Month | 24 | Day |
Last modified on
| 2014 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002875
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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