UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040583 |
|---|---|
| Receipt number | R000046319 |
| Scientific Title | Registry of Conduction System Pacing |
| Date of disclosure of the study information | 2021/04/13 |
| Last modified on | 2023/10/14 17:04:58 |
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Basic information
Public title
Registry of Conduction System Pacing
Acronym
Registry of Conduction System Pacing
Scientific Title
Registry of Conduction System Pacing
Scientific Title:Acronym
Registry of Conduction System Pacing
Region
| Japan |
Condition
Condition
Atrioventricular (AV) block
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the current status of Conduction System Pacing for patients with atrioventricular block
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Conduction System Pacing implantation results
Key secondary outcomes
Postoperative complications
1 year after implantation (device information, existence of survival)
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.Class I, IIa,or IIb indications for pacing therapy for atrioventricular block of II degrees or higher
2.Echocardiographic left ventricular contractility (Ejection fraction: EF)> 35%
Key exclusion criteria
1.Age under 20 at the time of implantation
2.Patients who could not obtain consent to participate in the study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Eriko |
| Middle name | |
| Last name | Hasumi |
Organization
The University of Tokyo Hospital
Division name
Department of Cardiovascular Medicine
Zip code
113-8655
Address
7-3-1 Hngo Bunkyo-ku Tokyo
TEL
03-3815-5411
ehasmi-circ@umin.ac.jp
Public contact
Name of contact person
| 1st name | Eriko |
| Middle name | |
| Last name | Hasumi |
Organization
The University of Tokyo Hospital
Division name
Department of Cardiovascular Medicine
Zip code
113-8655
Address
7-3-1 Hngo Bunkyo-ku Tokyo
TEL
03-3815-5411
Homepage URL
ehasmi-circ@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
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
The University of Tokyo Hospital
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-3815-5411
ethics@m.u-tokyo.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
| 2021 | Year | 04 | Month | 13 | 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
None
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 12 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A prospective observational study
Management information
Registered date
| 2020 | Year | 05 | Month | 29 | Day |
Last modified on
| 2023 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046319
