UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000036505
Receipt number R000040753
Scientific Title Atrial pacing to unmask the presence of epicardial muscular fibers connecting the right-sided pulmonary veins and right atrium
Date of disclosure of the study information 2019/04/15
Last modified on 2021/10/15 11:49:05

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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 or person

Institute

Ibaraki Prefectural Central Hospital

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040753


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name