UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043497 |
|---|---|
| Receipt number | R000049670 |
| Scientific Title | Short-term and long-term safety and efficacy of leadless pacemaker |
| Date of disclosure of the study information | 2021/03/02 |
| Last modified on | 2021/03/02 14:13:29 |
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Basic information
Public title
Short-term and long-term safety and efficacy of leadless pacemaker
Acronym
Safety and efficacy of leadless pacemaker
Scientific Title
Short-term and long-term safety and efficacy of leadless pacemaker
Scientific Title:Acronym
Safety and efficacy of leadless pacemaker
Region
| Japan |
Condition
Condition
Bradycardia
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of leadless pacemaker and to identify the fluoroscopic predictors for capture threshold post-implant
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Electrical parameter and complication of short-term and long-term after leadless pacemaker.
Key secondary outcomes
Pre-deployment direction of the delivery catheter in the multiple fluoroscopic view and post deployment capture threshold at implantation.
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
Permanent pacing indication class I and IIa for bradycardia or conduction system disturbance.
Key exclusion criteria
age of less than 20 years-old
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Toshiaki |
| Middle name | |
| Last name | Sato |
Organization
Kyorin University, Medical school
Division name
Division of Advanced Arrhythmia Management
Zip code
181-8611
Address
6-20-2 Shinkawa, Mitaka-City, Tokyo
TEL
0422-47-5511
toshiaki_sato@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshiaki |
| Middle name | |
| Last name | Sato |
Organization
Kyorin University, Medical school
Division name
Division of Advanced Arrhythmia Management
Zip code
181-8611
Address
6-20-2 Shinkawa, Mitaka
TEL
0422-47-5511
Homepage URL
toshiaki_sato@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Kyorin University, Medical school
Institute
Department
Personal name
Funding Source
Organization
Kyorin University, Medical school
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
Faculty of Medicine Research Ethics Committee, Kyorin University
Address
6-20-2 Shinkawa, Mitaka
Tel
+81-422-47-5513
ec@ks.kyorin-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
| 2021 | Year | 03 | 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
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
| 2020 | Year | 04 | Month | 04 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 04 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 04 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Single center observational study
Management information
Registered date
| 2021 | Year | 03 | Month | 02 | Day |
Last modified on
| 2021 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049670
