UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038608 |
|---|---|
| Receipt number | 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 | 2022/11/25 14:20:23 |
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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
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
MIYABI_OFFICE@quintiles.com
Sponsor or person
Institute
Johnson and Johnson K.K.
Institute
Department
Personal name
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
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
NA
Publication of results
Partially published
Result
URL related to results and publications
https://www.aphrs2022singapore.com/scientific-programme-detailed
Number of participants that the trial has enrolled
1011
Results
A total of 1,011 subjects in 50 sites were enrolled in this study. Of the 1,011 subjects, 3 subjects did not have a study catheter (Thermocool SmartTouch or Thermocool SmartTouch SF catheters)inserted and were excluded from the study.
Most of the subjects (93.27%; 943/1,011)completed the study.
Results date posted
| 2022 | Year | 11 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Target enrollment for this registry was a total of 1,000 patients with paroxysmal or early persistent AF who had been deemed as appropriate candidates for treatment with RF ablation catheters using CF technology and AI under standard-of-care practice in Japan.
It was recommended that approximately 30% of patients would have persistent AF.
Participant flow
Target enrollment for this registry was a total of 1,000 patients with paroxysmal or early persistent AF who had been deemed as appropriate candidates for treatment with RF ablation catheters using CF technology and AI under standard-of-care practice in Japan.
It was recommended that approximately 30% of patients would have persistent AF.
Adverse events
In the mITT population (N=1,007), incidence of PAEs was 0.89% (95% exact binomial confidence interval [ hereinafter, 95% CI]: 0.41, 1.69). There were 10 PAEs that occurred in 9 subjects within 7 days after the procedure.
Outcome measures
Percentage of subjects with PVI at the end of the procedure was 99.70% (999/1,002 [95% CI: 99.13, 99.94]).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
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 | 11 | Month | 08 | Day |
Date of closure to data entry
| 2022 | Year | 01 | Month | 31 | Day |
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
| 2022 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044002
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