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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000043655
Receipt No. 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 2021/03/18

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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
Email 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
Email satoshi.hayashida1@gmail.com

Sponsor
Institute Nihon University School of Medicine
Institute
Department

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
Email 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 No longer recruiting
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

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
2021 Year 03 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049853

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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