UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034017 |
|---|---|
| Receipt number | R000037781 |
| Scientific Title | Detection of atrial fibrillation using wearable pulse wave sensor |
| Date of disclosure of the study information | 2018/10/15 |
| Last modified on | 2022/03/08 09:09:43 |
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Basic information
Public title
Detection of atrial fibrillation using wearable pulse wave sensor
Acronym
Detection of atrial fibrillation using wearable pulse wave sensor
Scientific Title
Detection of atrial fibrillation using wearable pulse wave sensor
Scientific Title:Acronym
Detection of atrial fibrillation using wearable pulse wave sensor
Region
| Japan |
Condition
Condition
atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate if a wearable pulse wave sensor can detect the oscillation of heartbeat evoked by atrial fibrillation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The concordance rate between the interval of heartbeats assessed by Holter ECG and the wearable pulse wave sensor.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
To wear the noninvasive pulse wave sensor, for 12 to 24 hours.
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
Healthy subjects, and patients who visit Tokyo Medical and Dental University Medical Hospital for the treatment of atrial fibrillation.
Key exclusion criteria
Subjects who are not eligible for Holter electrocardiography recording
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Tetsuo |
| Middle name | |
| Last name | Sasano |
Organization
Tokyo Medical and Dental University
Division name
Department of Cardiovascular Medicine
Zip code
113-8519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5231
sasano.bi@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuo] |
| Middle name | |
| Last name | Sasano |
Organization
Tokyo Medical and Dental University
Division name
Department of Cardiovascular Medicine
Zip code
113-8519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5231
Homepage URL
sasano.bi@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
Tel
03-5803-5096
syomu1.adm@tmd.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
| 2018 | Year | 10 | Month | 15 | 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
| 2018 | Year | 09 | Month | 27 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 04 | Day |
Last modified on
| 2022 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037781
