UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008501 |
|---|---|
| Receipt number | R000009542 |
| Scientific Title | Attain Success Japan Study |
| Date of disclosure of the study information | 2012/07/24 |
| Last modified on | 2016/01/27 11:58:47 |
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Basic information
Public title
Attain Success Japan Study
Acronym
Attain Success Japan Study
Scientific Title
Attain Success Japan Study
Scientific Title:Acronym
Attain Success Japan Study
Region
| Japan |
Condition
Condition
Heart Failure
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Medtronic Japan co., Ltd. is sponsoring the Attain Success Japan Study, a prospective, non-randomized, multi-center, post-market observational clinical trial. The purpose of this trial is to assess Attain left-heart lead implant success and related complication rate.
For the Attain Success Study, implant success is defined as final successful placement of the left-heart lead in the coronary vein branch.
All subjects who have had the Attain left-heart lead implant attempt will be used to consider Attain left-heart lead implant success rate. All Subject who have had a successful Attain left-heart lead implant will be used to consider Attain left-heart lead related complication rate.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. To assess the implant success rate for the Attain left-heart leads.
2. To assess Attain left-heart lead related complication rate through three months.
Key secondary outcomes
1. To assess left-heart pacing threshold measured by left ventricular capture management (LVCM) and manual left ventricular capture threshold test at three month visit.
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
1. Subject is at least 20 years of age or older.
2. Subject will be implanted with Medtronic CRT device and Medtronic left-heart lead. The implant procedure may include upgrades to CRT from IPG or ICD.
3. Subject satisfies indications for Japanese CRT implantation.
Key exclusion criteria
1. Subject is enrolled in a concurrent study with the exception of a study approved by the Medtronic Clinical Trial Leader prior to enrollment.
2. Subject has existing CRT system implanted or was previously implanted with a CRT system.
3. Subject who will undergo an implant of either Medtronic Model 5071 Sutureless Myocardial Pacing Lead, Model 4968 CapSure Epi bipolar Epicardial Pacing Lead, or Model 4965 Epicardial Pacing Lead used as left-heart lead.
Target sample size
347
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Ando |
Organization
Kokura Memorial Hospital
Division name
Department of Cardiology
Zip code
Address
3-2-1, Asano, Kokura Kita-ku, Kitakyushu, Fukuoka
TEL
093-511-2000
kenji-ando@live.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Yoshimura |
Organization
Medtronic Japan Co., Ltd.
Division name
CRHF Clinical
Zip code
Address
2-1-14 Higashi Shimbashi, Minato-ku, Tokyo 105-0021 Japan
TEL
03-6430-7023
Homepage URL
hiroyuki.yoshimura@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 | 07 | Month | 24 | 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 | 05 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective, non-randomized, multicenter, observational study.
Management information
Registered date
| 2012 | Year | 07 | Month | 23 | Day |
Last modified on
| 2016 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009542
| 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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