UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049853