UMIN-CTR 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
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
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
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/ctr_e/ctr_view.cgi?recptno=R000040753
