UMIN-CTR Clinical Trial

Basic information
Public title	Prediction of atrioventricular conduction disturbance after ablation of persistent atrial fibrillation
Acronym	Prediction of atrioventricular conduction disturbance after ablation of persistent atrial fibrillation
Scientific Title	Prediction of atrioventricular conduction disturbance after ablation of persistent atrial fibrillation
Scientific Title:Acronym	Prediction of atrioventricular conduction disturbance after ablation of persistent atrial fibrillation
Region	Japan

Condition
Condition	atrial fibrillaiton
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	we investigated the relationship between preablation heart rate and concomitant AVCD after ablation in persistent AF, and we searched for predictors of atrioventricular conduction disturbances
Basic objectives2	Others
Basic objectives -Others	we investigated the relationship between preablation heart rate and concomitant AVCD after ablation in persistent AF, and we searched for predictors of atrioventricular conduction disturbances
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	AVCD in the chronic phase 12 months after ablation
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	We retrospectively analyzed consecutive patients with persistent AF who were referred to Toyama Prefectural Central Hospital in Japan between May 2018 and April 2020 for their first ablation procedure.
Key exclusion criteria	We excluded patients with a cardiac-implanted electronic device (CIED) at baseline.
Target sample size	175

Research contact person
Name of lead principal investigator	1st name Akio Middle name Last name Chikata
Organization	Toyama Prefectural Central Hospital
Division name	Department of Cardiology
Zip code	9308550
Address	2-2-78 Nishi-nagae, Toyama
TEL	076-424-1531
Email	akio.chikata@gmail.com

Public contact
Name of contact person	1st name Akio Middle name Last name Chikata
Organization	Toyama Prefectural Central Hospital
Division name	Department of Cardiology
Zip code	9308550
Address	2-2-78 Nishi-nagae, Toyama
TEL	076-424-1531
Homepage URL
Email	akio.chikata@gmail.com

Sponsor
Institute	Toyama Prefectural Central Hospital
Institute
Department

Funding Source
Organization	Non
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	Toyama Prefectural Central Hospital
Address	2-2-78 Nishi-nagae, Toyama
Tel	076-424-1531
Email	byoin@esp.pref.toyama.lg.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	2023 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	175
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	2022 Year 06 Month 01 Day
Date of IRB	2022 Year 05 Month 13 Day
Anticipated trial start date	2022 Year 06 Month 01 Day
Last follow-up date	2022 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We included only patients with sinus rhythm on 12-lead ECG at 12 months after the first procedure, regardless of AF recurrence or repeat ablation.

Management information
Registered date	2022 Year 10 Month 10 Day
Last modified on	2022 Year 10 Month 10 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056009