UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050926 |
|---|---|
| Receipt number | R000058050 |
| Scientific Title | Investigation of Factors Affecting Atrial Mechanical Sensing in Leadless Pacemakers |
| Date of disclosure of the study information | 2023/05/08 |
| Last modified on | 2023/10/31 11:13:27 |
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Basic information
Public title
Investigation of Factors Affecting Atrial Mechanical Sensing in Leadless Pacemakers
Acronym
Investigation of Factors Affecting Atrial Mechanical Sensing in Leadless Pacemakers
Scientific Title
Investigation of Factors Affecting Atrial Mechanical Sensing in Leadless Pacemakers
Scientific Title:Acronym
Investigation of Factors Affecting Atrial Mechanical Sensing in Leadless Pacemakers
Region
| Japan |
Condition
Condition
bradyarrhythmia
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine AV synchronization rates and factors related to implantation status in newly implanted Medtronic leadless pacemakers with atrial mechanical sensing (Micra AV) in Japan.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
AV synchronization rate (device data AM-Vp and AM-Vs rates) in relation to various parameters
1) Relationship with patient background (age, BMI, NYHA classification, frailty, underlying disease, etc.)
2) Pacemaker parameters at the time of implantation
3) Position of implantation (postoperative imaging: CT, echocardiography)
4) Parameter setting after implantation
Key secondary outcomes
1) Changes in Cardiac Functional Status by Adjustment of AV Synchronization Ratio
2) Change in AV synchrony rate over time
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
Patients scheduled for Medtronic leadless maker implantation with atrial mechanical sensing capability in Japan who meet all of the following inclusion criteria.
1) Those who have medical record information during the observation period.
2) Those who have received a full explanation of their participation in this study, and who have obtained the free and voluntary written consent of the patient or a surrogate after full understanding of the situation.
Key exclusion criteria
1) Patients who cannot be expected to have atrial synchronization or ventricular pacing activation
2) Patients suffering from chronic atrial fibrillation
3) Patients who are unable to receive regular post-implantation visits
4) Patients who cannot understand the study
5) Patients deemed inappropriate by the investigator
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | KOJI |
| Middle name | |
| Last name | FUKUDA |
Organization
International University Health and Welfare Hospital
Division name
Arrhythmia Center
Zip code
329-2763
Address
537-3, Iguchi, Nasushiobara, Japan
TEL
0287-39-3060
fukuda-k@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | KOJI |
| Middle name | |
| Last name | FUKUDA |
Organization
International University Health and Welfare Hospital
Division name
Arrhythmia Center
Zip code
329-2763
Address
537-3, Iguchi, Nasushiobara, Japan
TEL
0287-39-3060
Homepage URL
fukuda-k@iuhw.ac.jp
Sponsor or person
Institute
International University Health and Welfare Hospital
Institute
Department
Personal name
Koji Fukuda
Funding Source
Organization
Medtronic Japan Co., Ltd
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
International University of Health and Welfare
Address
2600-1, Kitakanemaru, Otawara, Japan
Tel
0287-24-3125
s-rinri@iuhw.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 | 05 | Month | 08 | 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 | 03 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study is an observational study of patients scheduled for Medtronic leadless maker implantation with atrial mechanical sensing capability in Japan who meet all of the following inclusion criteria and none of the exclusion criteria.
The overall study period is 2 years and 6 months
Enrollment period: 2 years
follow-up period: 6 months post-implantation
The following data are collected; baseline patient characteristics, various image data (CT, Cardiac UCG, perspective image et al.), blood examination data, and implanted device data.
Management information
Registered date
| 2023 | Year | 04 | Month | 25 | Day |
Last modified on
| 2023 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058050
