UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055490 |
|---|---|
| Receipt number | R000063401 |
| Scientific Title | Usefulness of Chest and/or Cardiac CTA for Leadless Pacemaker Implantation |
| Date of disclosure of the study information | 2024/09/11 |
| Last modified on | 2026/01/02 17:01:09 |
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Basic information
Public title
Usefulness of Chest and/or Cardiac Computed Tomographic Angiography for Leadless Pacemaker Implantation
Acronym
Usefulness of Chest and/or Cardiac CTA for Leadless Pacemaker Implantation
Scientific Title
Usefulness of Chest and/or Cardiac CTA for Leadless Pacemaker Implantation
Scientific Title:Acronym
Usefulness of Chest and/or Cardiac CTA for Leadless Pacemaker Implantation
Region
| Japan |
Condition
Condition
Patients implanted with a leadless pacemaker
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study investigates the anatomical relationships of the right heart system associated with imappropriate placement or complications of leadless pacemaker implantation in patients who underwent cardiac CT and had a leadless pacemaker implanted.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The presence of perioperative complications and inappropriate placement
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
> 18 years old
patients who underwent cardiac CT and had a leadless pacemaker implanted.
Key exclusion criteria
patients with leadless pacemaker who did not did not undergo pre- and/or postoperative chest or cardiac CTA
patients for whom analysis of chest CT or cardiac CT was not possible.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Koike |
Organization
Toho university
Division name
Department of Cardiovascular Medicine
Zip code
143-8541
Address
6-11-1 Omorinishi Otaku Tokyo
TEL
03-3762-4151
hideki.koike@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Koike |
Organization
Toho University Ohashi Medical Center
Division name
IRB
Zip code
143-8541
Address
6-11-1 Omorinishi Otaku Tokyo
TEL
03-5763-6534
Homepage URL
omori.rinri@ext.toho-u.ac.jp
Sponsor or person
Institute
Toho university
Institute
Department
Personal name
Funding Source
Organization
Medtronic
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
Toho university
Address
6-11-1 Omorinishi Otaku Tokyo
Tel
03-5763-6534
omori.rinri@ext.toho-u.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
| 2024 | Year | 09 | Month | 11 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 08 | Month | 14 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a retrospective and prospective observational study.
Subjects: Patients who underwent leadless pacemaker implantation at our hospital and had chest CT or cardiac CT performed. Retrospective period: From October 1, 2017, to April 30, 2024 (subject to change depending on ethical approval). Prospective period: From the date of ethical approval to December 31, 2026 (planned for 3 years after ethical approval).
Management information
Registered date
| 2024 | Year | 09 | Month | 11 | Day |
Last modified on
| 2026 | Year | 01 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063401
