UMIN-CTR Clinical Trial

Basic information
Public title	Atrial pacing to unmask the presence of epicardial muscular fibers connecting the right-sided pulmonary veins and right atrium
Acronym	Epicardial muscular fibers connecting the right-sided PVs and RA
Scientific Title	Atrial pacing to unmask the presence of epicardial muscular fibers connecting the right-sided pulmonary veins and right atrium
Scientific Title:Acronym	Epicardial muscular fibers connecting the right-sided PVs and RA
Region	Japan

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

Objectives
Narrative objectives1	To electrophysiologically prove the presence of epicardial muscular connections between the right atrium and pulmonary venous carina
Basic objectives2	Others
Basic objectives -Others	To evaluate the efficacy of catheter ablation of the epicardial connections
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Accuracy of the differential pacing methods.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Maneuver
Interventions/Control_1	Pacing manuevers at the pulmonary veins and atrium during catheter ablation of atrial fibrillation
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	Patients who undergo catheter ablation of atrial fibrillation and presented to the laboratory in sinus rhythm
Key exclusion criteria	long-standing persistent atrial fibrillation
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Kentaro Middle name Last name Yoshida
Organization	Ibaraki Prefectural Central Hospital
Division name	Depertment of Cardiology
Zip code	309-1793
Address	6528 Koibuchi, Kasama, Ibaraki
TEL	0296-77-1121
Email	kentaroyo@nifty.com

Public contact
Name of contact person	1st name Kentaro Middle name Last name Yoshida
Organization	Ibaraki Preferal Central Hospital
Division name	Depertment of Cardiology
Zip code	309-1793
Address	6528 Koibuchi, Kasama, Ibaraki
TEL	0296-77-1121
Homepage URL
Email	kentaroyo@nifty.com

Sponsor
Institute	Ibaraki Prefectural Central Hospital
Institute
Department

Funding Source
Organization	University of Tsukuba
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	Ibaraki Prefectural Central Hospital
Address	6528 Koibuchi, Kasama, Ibaraki
Tel	0296-77-1121
Email	j-kishi@chubyoin.pref.ibaraki.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	2019 Year 04 Month 15 Day

Related information
URL releasing protocol	https://onlinelibrary.wiley.com/doi/10.1111/jce.14835
Publication of results	Published

Result
URL related to results and publications	https://onlinelibrary.wiley.com/doi/10.1111/jce.14835
Number of participants that the trial has enrolled	133
Results	The prevalence of carina breakthrough during SR was higher in the EC-group than the gap-group (18 [95%] vs. 1 [4%] patients, p < .0001). The intervalSR-CS was larger in the EC-group versus gap-group (71 [interquartile range, 57-97] vs. 6 [2-9] ms, p < .0001). In all patients with an EC, RA ablation resulted in delay (32 [20-40] ms) (N = 15) or elimination of PV potentials (N = 5).
Results date posted	2021 Year 10 Month 15 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	This study included 133 consecutive patients. After one round of ablation, electrograms at the posterior antrum outside the ablation line were recorded during sinus rhythm (SR) and coronary sinus (CS) pacing, and intervals between the antral and PV potentials were measured in each rhythm.
Participant flow	This study included 133 consecutive patients　 undergoing pulmonary vein isolation.
Adverse events	none
Outcome measures	An EC can be efficiently discriminated from a conduction gap by a simple pacing maneuver.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 02 Month 07 Day
Date of IRB	2019 Year 03 Month 07 Day
Anticipated trial start date	2019 Year 03 Month 08 Day
Last follow-up date	2020 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 04 Month 14 Day
Last modified on	2021 Year 10 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040753