UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025979 |
|---|---|
| Receipt number | R000029665 |
| Scientific Title | Accelerometer assessment of daily physical activity and prognosis after catheter ablation of atrial fibrillation |
| Date of disclosure of the study information | 2017/03/01 |
| Last modified on | 2019/08/06 18:03:58 |
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Basic information
Public title
Accelerometer assessment of daily physical activity and prognosis after catheter ablation of atrial fibrillation
Acronym
Accelerometer assessment of daily physical activity and prognosis after catheter ablation of atrial fibrillation
Scientific Title
Accelerometer assessment of daily physical activity and prognosis after catheter ablation of atrial fibrillation
Scientific Title:Acronym
Accelerometer assessment of daily physical activity and prognosis after catheter ablation of atrial fibrillation
Region
| Japan |
Condition
Condition
Atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate daily physical activity and prognosis after catheter ablation of atrial fibrillation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
AF recurrence after the ablation
Key secondary outcomes
Physical activity, degree of AF symptoms
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver | Other |
Interventions/Control_1
Assessment of daily physical activity using accelerometer and questionnaire from 3-4 weeks before to 6 months after the ablation procedure
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
1) Patients who are scheduled to undergo catheter ablation of AF for the first time in Nagoya university hospital
2) Patients who are able to put on anccelerometer and are followed-up during 6 months after the ablation.
Key exclusion criteria
Patients who do not agree the study inclusion
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Yanagisawa |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Advanced Cardiovascular Therapeutics
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8550, Japan.
TEL
81-52-744-2147
yanagisawa-sato@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Yanagisawa |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Advanced Cardiovascular Therapeutics
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, 466-8550, Japan.
TEL
81-52-744-2147
Homepage URL
yanagisawa-sato@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine. Department of Advanced Cardiovascular Therapeutics
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research
Suzuken Memorial Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Nagoya University Ethics Committee
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi4668550, Japan.
Tel
81-52-744-2423
camcr@med.nagoya-u.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
名古屋大学医学部附属病院(愛知県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | 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
20
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
| 2017 | Year | 01 | Month | 28 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 26 | Day |
Last follow-up date
| 2019 | 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
| 2017 | Year | 02 | Month | 02 | Day |
Last modified on
| 2019 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029665
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
