UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047242 |
|---|---|
| Receipt number | R000053881 |
| Scientific Title | Impact of phrenic nerve stimulation from neck during cryo-balloon ablation |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2025/05/10 10:38:28 |
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Basic information
Public title
Impact of phrenic nerve stimulation from neck during cryo-balloon ablation
Acronym
Impact of phrenic nerve stimulation from neck during cryo-balloon ablation
Scientific Title
Impact of phrenic nerve stimulation from neck during cryo-balloon ablation
Scientific Title:Acronym
Impact of phrenic nerve stimulation from neck during cryo-balloon ablation
Region
| Japan |
Condition
Condition
atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to determine usefulness of phrenic nerve stimulation from neck
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
phrenic nerve palsy, procedural time, skin injury
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
| Maneuver |
Interventions/Control_1
phrenic nerve stimulation from neck
Interventions/Control_2
non-phrenic nerve stimulation from neck
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
atrial fibrillation
Key exclusion criteria
procedures except cryo-balloon ablation
Target sample size
100
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 | 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
Homepage URL
matakemo@outlook.jp
Sponsor or person
Institute
Steel Memorial Yawata Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Second Department of Internal Medicine, University of Occupational and Environmental Health
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
| 2022 | Year | 04 | Month | 01 | 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
Completed
Date of protocol fixation
| 2022 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 05 | 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
| 2022 | Year | 03 | Month | 22 | Day |
Last modified on
| 2025 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053881
