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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033266
Receipt No. R000037928
Official scientific title of the study The study for detecting the recurrence of atrial fibrillation by using home blood pressure monitoring device and investigating the related factors
Date of disclosure of the study information 2018/07/05
Last modified on 2018/07/04

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Basic information
Official scientific title of the study The study for detecting the recurrence of atrial fibrillation by using home blood pressure monitoring device and investigating the related factors
Title of the study (Brief title) The study for detecting the recurrence of atrial fibrillation
Region
Japan

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

Objectives
Narrative objectives1 1.To verify the effectiveness of detecting the recurrence of atrial fibrillation by using home blood pressure monitoring device
2.To investigate the relationship between the home BP status after catheter ablation and the recurrence of atrial fibrillation
3.To investigate the relationship between the home BP status before catheter ablation and electrophysiological findings
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Comparison of accuracy in AF Detection between the Holter electrocardiography and the home blood pressure monitoring device with irregular heart beat detection algorism
Key secondary outcomes 1.Relationship between the recurrence of atrial fibrillation and blood pressure levels or blood pressure variability
2.Relationship between the atrial arrhythmogenic substrate and blood pressure levels or blood pressure variability
3.Relationship between the recurrence of atrial fibrillation and each exam findings
4.For the recurrence cases, comparison between the first and second electrophysiological findings

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 Patients are asked to measure home blood pressure in the morning and before going to bed for 18 months by using home blood pressure monitoring device with irregular heart beat detection algorism.
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
85 years-old >
Gender Male and Female
Key inclusion criteria (1) Patients who are scheduled catheter ablation for atrial fibrillation
(2) Male or female, age 20 to 84 years.
(3) Patients with written informed consent.
Key exclusion criteria Patients who meet the following criteria:
(1)Less than 1 month since onset of myocardial infarction, unstable angina or peripheral artery disease.
(2) Patients with systemic embolism, or less than 3 month since onset of stroke.
(3) Patients with malignant tumor (no improvement in symptoms).
(4) Life expectancy of less than one year due to other pre-existing diseases.
(5) Patients judged as unsuitable for the study by study investigators.
Target sample size 100

Research contact person
Name of lead principal investigator Kazuomi Kario
Organization Jichi Medical University School of Medicine
Division name Division of Cardiovascular, Medicine, Department of Medicine
Address 3311-1 Yakushiji, Shimotsuke-shi,Tochigi, Japan 329-0498
TEL 0285-58-7538
Email kkario@jichi.ac.jp

Public contact
Name of contact person Kazuomi Kario
Organization Jichi Medical University School of Medicine
Division name Division of Cardiovascular, Medicine, Department of Medicine
Address 3311-1 Yakushiji, Shimotsuke-shi,Tochigi, Japan 329-0498
TEL 0285-58-7538
Homepage URL
Email kkario@jichi.ac.jp

Sponsor
Institute Jichi Medical University School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor A&D Co., Ltd.
Name of secondary funder(s)

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 自治医科大学附属病院(栃木県)

Other administrative information
Date of disclosure of the study information
2018 Year 07 Month 05 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 06 Month 27 Day
Anticipated trial start date
2018 Year 07 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 07 Month 04 Day
Last modified on
2018 Year 07 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037928

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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