UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049669 |
|---|---|
| Receipt number | R000056470 |
| Scientific Title | Follow-up study in patients with re-implanted devices after transvenous lead extraction |
| Date of disclosure of the study information | 2022/12/02 |
| Last modified on | 2022/12/02 11:24:34 |
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Basic information
Public title
Follow-up study in patients with re-implanted devices after transvenous lead extraction
Acronym
Follow-up study in patients with re-implanted devices after transvenous lead extraction
Scientific Title
Follow-up study in patients with re-implanted devices after transvenous lead extraction
Scientific Title:Acronym
Follow-up study in patients with re-implanted devices after transvenous lead extraction
Region
| Japan |
Condition
Condition
Patients undergoing transvenous lead extraction(TLE) for implantable cardiac device infection or other reasons
Classification by specialty
| Cardiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will investigate the stimulation threshold, sensing wave height, lead resistance, etc. of patients who had device re-implantation after TLE from past records to clarify the transition of follow-up data. The appropriate follow-up interval for patients who have had a device removed and reimplanted will also be examined accordingly. Based on the results, we will estimate the appropriate follow-up intervals for early detection of abnormalities in lead devices, and improve the time constraints and psychological anxiety caused by excessive device checks.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Device follow-up data for patients with device reimplanted after TLE between 2016 and 2022
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. TLE and reimplantation of the device
2. at least one device follow-up after device implantation and discharge from the hospital
Key exclusion criteria
1. If the reimplanted device is an S-ICD (subcutaneous implantable cardioverter defibrillator)
2. When device follow-up has not been performed
Target sample size
162
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Isawa |
Organization
Sendai Kousei Hospital
Division name
Department of cardiology
Zip code
980-0873
Address
4-5 Hirose-machi, Aobaku, Sendai, Miyagi, Japan.
TEL
022-222-6181
isa_tsuyo@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Isawa |
Organization
Sendai Kousei Hospital
Division name
Department of cardiology
Zip code
980-0873
Address
4-5 Hirose-machi, Aobaku, Sendai, Miyagi, Japan.
TEL
022-222-6181
Homepage URL
isa_tsuyo@yahoo.co.jp
Sponsor or person
Institute
Sendai Kousei Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Institutional Review Board on Sendai Kousei Hospital
Address
4-5, Hirose-machi, Aobaku, Sendai, Miyagi, Japan
Tel
022-222-6181
s.takahashi@sendai-kousei-hospital.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
| 2022 | Year | 12 | Month | 02 | 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
162
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 28 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cardiac implantable device follow-up data from January 2017 to July 2022 were used .
Management information
Registered date
| 2022 | Year | 12 | Month | 02 | Day |
Last modified on
| 2022 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056470
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
