UMIN-CTR Clinical Trial

Basic information
Public title	A Tailor-made Durable Ablation Strategy for Atrial Fibrillation Based on the PV Antrum Wall Thickness
Acronym	Force-time Integral / Wall Thickness (FTIW) Based PVI Ablation Strategy
Scientific Title	A Tailor-made Durable Ablation Strategy for Atrial Fibrillation Based on the PV Antrum Wall Thickness
Scientific Title:Acronym	Force-time Integral / Wall Thickness (FTIW) Based PVI Ablation Strategy
Region	Japan

Condition
Condition	Atrial fibrillation
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the incidence of pulmonary vein dormant conduction by adenosine triphosphate and the recurrence rate of atrial fibrillation after pulmonary vein isolation based on a pulmonary vein atrum wallthickness
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. Incidence of pulmonary vein dormant conduction 2. Atrial fibrillation recurrence rate in the short- and long-term period after ablation
Key secondary outcomes	1. Incidence of ipsilateral pulmonary vein isolation 2. Complication rate

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	18 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Atrial fibrillation
Key exclusion criteria	History of stroke and remote myocardial infarction within 3 months Presence of left atrial thrombosis
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Yasuo Middle name Last name Okumura
Organization	Division of Cardiology, Department of Medicine, Nihon University School of Medicine
Division name	Nihon University Itabashi Hospital
Zip code	1738610
Address	30-1 Ohyaguchi, Kamicho, Itabashi-Ku, Tokyo 173-8610, Japan
TEL	+81-3-3972-8111
Email	yasuwo128@yahoo.co.jp

Public contact
Name of contact person	1st name Yasuo Middle name Last name Okumura
Organization	Nihon University Itabashi Hospital
Division name	Division of Cardiology
Zip code	1738610
Address	30-1 Ohyaguchi, Kamicho, Itabashi-Ku, Tokyo 173-8610, Japan
TEL	+81-3-3972-8111
Homepage URL
Email	yasuwo128@yahoo.co.jp

Sponsor
Institute	Division of Cardiology, Department of Medicine, Nihon University School of Medicine
Institute
Department

Funding Source
Organization	Division of Cardiology, Department of Medicine, Nihon University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Nihon University Itabashi Hospital Clinical Research Center
Address	30-1 Oyaguchi-Kami Itabashi-Ku
Tel	0339728111
Email	komoda.nozomi@nihon-u.ac.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	2017 Year 04 Month 04 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
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	2016 Year 03 Month 03 Day
Date of IRB	2016 Year 05 Month 01 Day
Anticipated trial start date	2016 Year 03 Month 25 Day
Last follow-up date	2018 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	64 patients were enrolled. A subalanysis of this study was published in Journal of interventional cardiac electrophysiology

Management information
Registered date	2017 Year 04 Month 03 Day
Last modified on	2019 Year 10 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021668