UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051594 |
|---|---|
| Receipt number | R000058864 |
| Scientific Title | A novel hemostatic belt allowing ambulation soon after atrial fibrillation ablation |
| Date of disclosure of the study information | 2023/07/12 |
| Last modified on | 2024/01/11 12:20:04 |
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Basic information
Public title
A novel hemostatic belt allowing ambulation soon after atrial fibrillation ablation
Acronym
A novel hemostatic belt allowing ambulation soon after atrial fibrillation ablation
Scientific Title
A novel hemostatic belt allowing ambulation soon after atrial fibrillation ablation
Scientific Title:Acronym
A novel hemostatic belt allowing ambulation soon after atrial fibrillation ablation
Region
| Japan |
Condition
Condition
Atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess efficacy and safety of a novel hemostatic belt
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time from the onset of the application of the belt or compression bandage to ambulation
Key secondary outcomes
Satisfaction with the 2 hemostatic strategies on a scale of 1 to 10 (1=extremely dissatisfied, 10=extremely satisfied) (2) rebleeding or hematoma at the groin puncture site that required any medical attention or intervention including additional astriction, sutures, surgical intervention, or blood transfusion, and (3) adverse events resulting from the hemostatic strategies themselves such as skin problems, leg ischemia, or deep venous thrombosis
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Hemostasis of the right femoral venipuncture site with the use of the hemostatic belt
Interventions/Control_2
Hemostasis of the right femoral venipuncture site with the use of the conventional compression bandage
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
The subjects with atrial fibrillation who were scheduled to undergo radiofrequency catheter ablation for the first time
Key exclusion criteria
Subjects with the hip circumference was >120 cm
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Akinori |
| Middle name | |
| Last name | Sairaku |
Organization
National Hospital Organization Higashihiroshima Medical Center
Division name
Cardiology
Zip code
739-0041
Address
513 Jike, Saijo-cho, 739-0041, Higashihiroshima, Japan
TEL
082-423-2176
rjrgw059@ybb.ne.jp
Public contact
Name of contact person
| 1st name | Akinori |
| Middle name | |
| Last name | Sairaku |
Organization
National Hospital Organization Higashihiroshima Medical Center
Division name
Cardiology
Zip code
7300004
Address
513 Jike, Saijo-cho, 739-0041, Higashihiroshima, Japan
TEL
082-423-2176
Homepage URL
rjrgw059@ybb.ne.jp
Sponsor or person
Institute
Onomichi General Hospital
Institute
Department
Personal name
Funding Source
Organization
JMS 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
Research Committee of Onomichi General Hospital
Address
1-10-23 Hirahara, Onomichi, Japan
Tel
0848-22-8111
e.asami@hirokouren.or.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
OJH-202154
Org. issuing International ID_1
Research Committee of Onomichi General Hospital
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 | 07 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
doi: 10.1007/s12265-023-10417-2. Epub 2023 Aug 1.
Number of participants that the trial has enrolled
74
Results
A randomized trial comparing the belt with compression bandage in 74 AF patients demonstrated that the belt reduced time to ambulation without any rebleeding (340 [92.5-360] vs. 360 [360-360] min; P < 0.001) and satisfied more patients.
Results date posted
| 2024 | Year | 01 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 12 | Month | 16 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2023 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 07 | Month | 30 | Day |
Date analysis concluded
| 2023 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 07 | Month | 12 | Day |
Last modified on
| 2024 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058864
