UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037035 |
|---|---|
| Receipt number | R000042194 |
| Scientific Title | Effect of Catheter ablation on muscle sympathetic nerve activity in patient with atrial fibrillation |
| Date of disclosure of the study information | 2019/06/12 |
| Last modified on | 2021/12/24 18:52:28 |
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Basic information
Public title
Effect of Catheter ablation on muscle sympathetic nerve activity in patient with atrial fibrillation
Acronym
AFSNA
Scientific Title
Effect of Catheter ablation on muscle sympathetic nerve activity in patient with atrial fibrillation
Scientific Title:Acronym
AFMSNA
Region
| Japan |
Condition
Condition
patients with atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to investigate whether AF ablation affect muscle sympathetic nerve activity (MSNA).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
reduction in MSNA
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Catheter ablation
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
AF Patients who undergo CA
Key exclusion criteria
1) moderate to severe valvular heart disease
2)Obesity (BMI>30kg/m2)
3)poor controlled DM (HbA1c>10)
4)Sever Neuropathy
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | HISAYOSHI |
| Middle name | |
| Last name | MURAI |
Organization
Kanazawa University
Division name
Cardiology
Zip code
9200946
Address
Takaramachi 13-1 Kanazawa
TEL
0762652000
sakurasoma1209@yahoo.co.jp
Public contact
Name of contact person
| 1st name | HISAYOSHI |
| Middle name | |
| Last name | MURAI |
Organization
Kanazawa university
Division name
cardiology
Zip code
920-8641
Address
Takaramachi 13-1 Kanazawa
TEL
0762652000
Homepage URL
sakurasoma1209@yahoo.co.jp
Sponsor or person
Institute
Kanazawa university
Institute
Department
Personal name
Funding Source
Organization
Health insurance
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
Kanazawa University hospital
Address
Takaramachi 13-1
Tel
0762652238
sakurasoma1209@yahoo.co.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
| 2019 | Year | 06 | Month | 12 | 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
| 2019 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 06 | Month | 12 | Day |
Last modified on
| 2021 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042194
