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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005539
Receipt No. R000006571
Scientific Title the effect of appropriate treatment with continuous positive airway pressure (CPAP) on the recurrence of atrial fibrillation after radiofrequency catheter ablation
Date of disclosure of the study information 2011/05/01
Last modified on 2012/12/04

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Basic information
Public title the effect of appropriate treatment with continuous positive airway pressure (CPAP) on the recurrence of atrial fibrillation after radiofrequency catheter ablation
Acronym the effect of appropriate treatment with continuous positive airway pressure (CPAP) on the recurrence of atrial fibrillation after radiofrequency catheter ablation
Scientific Title the effect of appropriate treatment with continuous positive airway pressure (CPAP) on the recurrence of atrial fibrillation after radiofrequency catheter ablation
Scientific Title:Acronym the effect of appropriate treatment with continuous positive airway pressure (CPAP) on the recurrence of atrial fibrillation after radiofrequency catheter ablation
Region
Japan

Condition
Condition atrial fibrillation
sleep apnea syndrome
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to clarify the effect of appropriate treatment with CPAP on the recurrence of AF after radiofrequency catheter ablation for AF
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the recurrence of AF after radiofrequency catheter ablation for AF
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 the patients without sleep apnea syndrome
Interventions/Control_2 the patients with sleep apnea syndrome received CPAP therapy
Interventions/Control_3 the patients with sleep apnea syndrome not received CPAP therapy
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 pregnancy
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Aonuma Kazutaka
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
Email

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
Email

Sponsor
Institute Institute of Clinical Medicine, Graduate School of Comprehensive Human Sciences, University of Tsukuba
Institute
Department

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
Email

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 12 Month 01 Day
Date of closure to data entry
2011 Year 12 Month 01 Day
Date trial data considered complete
2011 Year 12 Month 01 Day
Date analysis concluded
2011 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 05 Month 01 Day
Last modified on
2012 Year 12 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006571

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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