UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051440 |
|---|---|
| Receipt number | R000058672 |
| Scientific Title | Validation study on sheath fluoroscopic images at the time of implanting a leadless pacemaker (Micra) and time until the placement of the device |
| Date of disclosure of the study information | 2023/06/23 |
| Last modified on | 2023/06/23 19:39:14 |
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Basic information
Public title
Validation study on sheath fluoroscopic images at the time of implanting a leadless pacemaker (Micra) and time until the placement of the device
Acronym
Validation study on sheath fluoroscopic images at the time of implanting a leadless pacemaker (Micra) and time until the placement of the device
Scientific Title
Validation study on sheath fluoroscopic images at the time of implanting a leadless pacemaker (Micra) and time until the placement of the device
Scientific Title:Acronym
Validation study on sheath fluoroscopic images at the time of implanting a leadless pacemaker (Micra) and time until the placement of the device
Region
| Japan |
Condition
Condition
bradycardia
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the relationship between the sheath fluoroscopic images and the implantation time of Micra.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total time to implant the Micra and number of attempts.
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
The patients who are planned to implant the leadless pacemaker (Micra).
Key exclusion criteria
The patients who are decided to be inappropriate to be enrolled in the study.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yuichi |
| Middle name | |
| Last name | Hori |
Organization
Dokkyo Medical University Saitama Medical Center
Division name
Caridology
Zip code
343-8555
Address
2-1-50 Minamikoshigaya, Koshigaya, Saitama
TEL
+81489651111
yuichi-h@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Yuichi |
| Middle name | |
| Last name | Hori |
Organization
Dokkyo Medical University Saitama Medical Center
Division name
Caridology
Zip code
343-8555
Address
2-1-50 Minami Koshigaya, Koshigaya, Saitama
TEL
+81489651111
Homepage URL
yuichi-h@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University Saitama Medical Center
Institute
Department
Personal name
Funding Source
Organization
Medtronic
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
institutional committee on human research at Dokkyo Medical University Saitama Medical Center
Address
2-1-50 Minami Koshigaya, Koshigaya, Saitama
Tel
+81489651111
yuichi-h@dokkyomed.ac.jp
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
| 2023 | Year | 06 | Month | 23 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
1. Acquisition of patient information
2. Confirm the fluoroscopic images of the sheath, and record the angle from the LAO and RAO view.
3. Record the total time for the implantation and the number of attempts.
Management information
Registered date
| 2023 | Year | 06 | Month | 23 | Day |
Last modified on
| 2023 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058672
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
