UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057904 |
|---|---|
| Receipt number | R000066191 |
| Scientific Title | Core Temperature Management Using Heat Insulation Blankets/System in Patients Undergoing Cryoballoon Ablation for Atrial Fibrillation Under General Anesthesia |
| Date of disclosure of the study information | 2025/05/19 |
| Last modified on | 2025/11/18 14:36:39 |
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Basic information
Public title
Core Temperature Management Using Heat Insulation Blankets/System in Patients Undergoing Cryoballoon Ablation for Atrial Fibrillation Under General Anesthesia
Acronym
Core Temperature Management during Atrial Fibrillation Ablation
Scientific Title
Core Temperature Management Using Heat Insulation Blankets/System in Patients Undergoing Cryoballoon Ablation for Atrial Fibrillation Under General Anesthesia
Scientific Title:Acronym
Core Temperature Management during Atrial Fibrillation Ablation
Region
| Japan |
Condition
Condition
patients undergoing ablation of atrial fibrillation
Classification by specialty
| Cardiology | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This randomized clinical trial assessed the efficacy of the heat insulation blanket/system in patients undergoing ablation for atrial fibrillation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoints of this study are 1) time to hemostasis, 2) awakening time from anesthesia, and 3) post operative complications.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
heat insulation blanket/system
Interventions/Control_2
without heat insulation blanket/system
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients undergoing atrial fibrillation ablation
Key exclusion criteria
The patients who do not agree
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Masao |
| Middle name | |
| Last name | Takemoto |
Organization
Steel Memorial Yawata Hospital
Division name
Cardiovascular Center
Zip code
8058508
Address
1-1-1 Harunomachi, Yahatahigashi-ku, Kitakyusyu, Japan
TEL
0936723176
matakemo@outlook.jp
Public contact
Name of contact person
| 1st name | Sachiko |
| Middle name | |
| Last name | Shimono |
Organization
Steel Memorial Yawata Hospital
Division name
Clinical study support room
Zip code
8058508
Address
1-1-1 Harunomachi, Yahatahigashi-ku, Kitakyusyu, Japan
TEL
0936723176
Homepage URL
shimono.s@ns.yawata-mhp.or.jp
Sponsor or person
Institute
others
Institute
Department
Personal name
Funding Source
Organization
none
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
Steel Memorial Yawata Hospital
Address
1-1-1 Harunomachi, Yahatahigashi-ku, Kitakyusyu, Japan
Tel
0936723176
shimono.s@ns.yawata-mhp.or.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
| 2025 | Year | 05 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 19 | Day |
Last modified on
| 2025 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066191
