UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005538 |
|---|---|
| Receipt number | R000006570 |
| Scientific Title | the impact of radiofrequency catheter ablation for atrial fibrillation on sleep apnea syndrome |
| Date of disclosure of the study information | 2011/05/01 |
| Last modified on | 2012/04/30 09:15:32 |
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Basic information
Public title
the impact of radiofrequency catheter ablation for atrial fibrillation on sleep apnea syndrome
Acronym
the impact of radiofrequency catheter ablation for atrial fibrillation on sleep apnea syndrome
Scientific Title
the impact of radiofrequency catheter ablation for atrial fibrillation on sleep apnea syndrome
Scientific Title:Acronym
the impact of radiofrequency catheter ablation for atrial fibrillation on sleep apnea syndrome
Region
| Japan |
Condition
Condition
atrial fibrillation
sleep apnea syndrome
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to investigate the efficacy of radiofrequency catheter ablation in the treatment of sleep apnea syndrome in consecutive patients who required a radiofrequency catheter ablation for atrial fibrillation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The polysomnographic recording were performed one day before and 1 week after the ablation, and the total duration and number of episodes of central or obstructive apnea or hypopnea were analyzed and compared.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
drug-refractory, persistent AF who underwent radiofrequency catheter ablation
Key exclusion criteria
the patients without problems related to sleep-disordered breathing, such as snoring, daytime sleepiness, frequent arousals at night, sleep apnea
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazutaka Aonuma |
Organization
Institute of Clinical Medicine, Graduate School of Comprehensive Human Sciences, University of Tsukuba
Division name
Department of Cardiology
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
029-853-3142
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Graduate School of Comprehensive Human Sciences, University of Tsukuba
Division name
Department of Cardiology
Zip code
Address
TEL
029-853-3142
Homepage URL
Sponsor or person
Institute
Institute of Clinical Medicine, Graduate School of Comprehensive Human Sciences, University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2011 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
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
Completed
Date of protocol fixation
| 2009 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 08 | Month | 01 | Day |
Other
Other related information
prospective
Management information
Registered date
| 2011 | Year | 05 | Month | 01 | Day |
Last modified on
| 2012 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006570
