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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000038608
Receipt No. R000044002
Scientific Title Multicenter Registry of AF Ablation with Ablation Index in Japan
Date of disclosure of the study information 2020/01/14
Last modified on 2020/11/18

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Basic information
Public title Japan Ablation Index Atrial Fibrillation Ablation Registry
Acronym MIYABI
Scientific Title Multicenter Registry of AF Ablation with Ablation Index in Japan
Scientific Title:Acronym MIYABI
Region
Japan

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

Objectives
Narrative objectives1 The primary purpose of this prospective registry is to obtain real-world clinical outcomes of atrial fibrillation (AF) ablation guided by Ablation Index (AI) with contact force (CF) technology in Japan.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes To assess acute and long-term clinical outcomes, including procedural efficiency, safety, and long-term effectiveness of catheter ablation with RF catheters guided by AI in patients with paroxysmal and early persistent AF in a Japanese population.
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

Not applicable
Gender Male and Female
Key inclusion criteria Subjects must meet all of the following inclusion criteria to be eligible for participation in this registry:
1.Patients who provide signed informed consent to participate in the registry
2.Patients with drug refractory symptomatic paroxysmal AF or patients with persistent AF for less than 6 months who, in the opinion of the investigator, are candidates for catheter ablation per standard-of-care
3.Patients who plan to have pulmonary vein isolation (PVI), of which AI is usable
4.Patients must be 20 years of age or older
5.Patients undergoing AF ablation for the first time
Key exclusion criteria Subjects who meet any of the following exclusion criteria are not eligible for enrollment:
1.Patients with persistent AF with a continuous episode lasting longer than 6 months or patients with long-standing persistent AF
2.Patients who previously underwent AF ablation
3.Women of childbearing potential who are, or plan to become, pregnant during the time of the study
4.Patients who have a life expectancy of less than 12 months
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Ken
Middle name
Last name Okumura
Organization Saiseikai Kumamoto Hospital
Division name Cardiology
Zip code 861-4193
Address 5-3-1 Chikami, Minami-ku, Kumamoto City, Kumamoto Prefecture
TEL 096-351-8000
Email MIYABI_OFFICE@quintiles.com

Public contact
Name of contact person
1st name Bunmoku
Middle name
Last name Tei
Organization IQVIA Services Japan K.K.
Division name Real World Evidence Services
Zip code 108-0074
Address 4-10-18 Takanawa, Minato-ku, Tokyo
TEL 090-9153-2474
Homepage URL
Email MIYABI_OFFICE@quintiles.com

Sponsor
Institute Johnson and Johnson K.K.
Institute
Department

Funding Source
Organization Johnson and Johnson K.K.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Saiseikai Kumamoto Hospital Medical Ethics Committe
Address 5-3-1 Chikami, Minami-ku, Kumamoto-City, Kumamoto prefecture
Tel 096-351-8000
Email rks@saiseikaikumamoto.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
2020 Year 01 Month 14 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 1011
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 No longer recruiting
Date of protocol fixation
2019 Year 10 Month 02 Day
Date of IRB
2019 Year 10 Month 21 Day
Anticipated trial start date
2020 Year 01 Month 14 Day
Last follow-up date
2021 Year 10 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study Design:Prospective, observational, multicenter registry
Planned recruitment period: Jan 2020 to Sep 2020
Recruitment subjects: Patients obtained written consent among the patients who met the selection criteria at the participating facilities within the registration period

Management information
Registered date
2019 Year 11 Month 18 Day
Last modified on
2020 Year 11 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044002

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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