UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043655 |
|---|---|
| Receipt number | R000049853 |
| Scientific Title | Modified Ablation Index: A Novel Determinant of Successful First-Pass Left Atrial Posterior Wall Isolation |
| Date of disclosure of the study information | 2021/03/20 |
| Last modified on | 2022/03/24 22:19:03 |
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Basic information
Public title
Observational study to clarify factors contributing to improved success rate of left atrial posterior wall isolation in patients with atrial fibrillation
Acronym
Study of Success Factors for Left Atrial posterior wall Isolation
Scientific Title
Modified Ablation Index: A Novel Determinant of Successful First-Pass Left Atrial Posterior Wall Isolation
Scientific Title:Acronym
Modified AI as a Determinant of First-Pass LAPWI
Region
| Japan |
Condition
Condition
Atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to examine whether the parameters such as wall thickness, local potential in left atrial posterior wall, and modified AI can be an index for predicting the success of left atrial posterior wall isolation in the patients with atrial fibrillation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Wall thickness and potential characteristics at left atrial posterior wall between the groups with successful LAPWI and failed LAPWI.
Key secondary outcomes
Age, sex, BW, BMI, CHADs2 score, comorbidities, history of atrial fibrillation, renal function, cardiac function, medication content ,and recurrence of atrial fibrillation after ablation between groups with successful LAPWI and failed LAPWI.
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
| 30 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Among patients who underwent catheter ablation for atrial fibrillation
(1) Patients who underwent ablation using the CARTO system of the 3D mapping system
(2) Patients whose potential in the left chamber can be measured without excess or deficiency
Key exclusion criteria
Patients who are judged by the principal investigator to be inappropriate as research subjects
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yasuo |
| Middle name | |
| Last name | Okumura |
Organization
Nihon University School of Medicine
Division name
Division of Cardiology
Zip code
173-8610
Address
30-1 Ohyaguchi-kamicho, Itabashi-ku, Tokyo, Japan
TEL
03-3972-8111
yasuwo128@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Hayashida |
Organization
Nihon University School of Medicine
Division name
Division of Cardiology
Zip code
173-8610
Address
30-1 Ohyaguchi-kamicho, Itabashi-ku, Tokyo, Japan
TEL
03-3972-8111
Homepage URL
satoshi.hayashida1@gmail.com
Sponsor or person
Institute
Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University School of Medicine
Address
30-1 Ohyaguchi-kamicho, Itabashi-ku, Tokyo, Japan
Tel
03-3972-8111
satoshi.hayashida1@gmail.com
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
| 2021 | Year | 03 | Month | 20 | 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
55
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
| 2019 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Exploratory observational study
Recruitment method: Patients who underwent catheter ablation for atrial fibrillation at our facility in August 2019-February 2020.
Management information
Registered date
| 2021 | Year | 03 | Month | 18 | Day |
Last modified on
| 2022 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049853
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
