UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051971 |
|---|---|
| Receipt number | R000058908 |
| Scientific Title | Detection of epicardial connection through intercaval bundle involving right pulmonary veins after ipsilateral circumferential ablation by intra atrial activation sequence pacing from right pulmonary vein |
| Date of disclosure of the study information | 2023/10/01 |
| Last modified on | 2023/08/22 12:06:29 |
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Basic information
Public title
Detection of epicardial connection through intercaval bundle involving right pulmonary veins after ipsilateral circumferential ablation by intra atrial activation sequence pacing from right pulmonary vein
Acronym
Detection of epicardial connection by right pulmonary vein pacing
Scientific Title
Detection of epicardial connection through intercaval bundle involving right pulmonary veins after ipsilateral circumferential ablation by intra atrial activation sequence pacing from right pulmonary vein
Scientific Title:Acronym
Detection of epicardial connection by right pulmonary vein pacing
Region
| Japan |
Condition
Condition
atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
An epicardial connection (EC) through the intercaval bundle (EC-ICB) between the right pulmonary vein (RPV) and the right atrium (RA) is one of the reasons for the need of carina ablation for PV isolation.
We evaluated the intra-atrial activation sequence during RPV pacing after failure of ipsilateral RPV isolation and sought to identify specific conduction patterns in the presence of the EC-ICB.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
If the RPV was not isolated by circumferential ablation or reconnected during the waiting period, an exit map during mid RPV carina pacing was created. If the earliest site of the exit map was the RA, the patient was classified into the EC-ICB group. During the exit map, intra-atrial activation sequence and RPV-HRA time were evaluated.
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 analyzed consecutive patients with AF who were referred to Toyama Prefectural Central Hospital in Japan between July 2021 and June 2023 for their first ablation procedures and underwent radiofrequency (RF) catheter ablation using CARTO 3 system (Biosense Webster, Inc.).
Key exclusion criteria
Non
Target sample size
220
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
930-8550
Address
2-2-78 Nishi-nagae, Toyama
TEL
076-424-1531
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
930-8550
Address
2-2-78 Nishi-nagae, Toyama
TEL
076-424-1531
Homepage URL
akio.chikata@gmail.com
Sponsor or person
Institute
Toyama Prefectural Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Toyama Prefectural Central Hospital
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
akio.chikata@gmail.com
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 | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
223
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
| 2023 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We evaluated the intra-atrial activation sequence during RPV pacing after failure of ipsilateral RPV isolation and sought to identify specific conduction patterns in the presence of the EC-ICB.
This study included 223 consecutive patients undergoing initial catheter ablation of atrial fibrillation. If the RPV was not isolated by circumferential ablation or reconnected during the waiting period, an exit map during mid RPV carina pacing was created. If the earliest site of the exit map was the RA, the patient was classified into the EC-ICB group. During the exit map, intra-atrial activation sequence and RPV-HRA time were evaluated.
Management information
Registered date
| 2023 | Year | 08 | Month | 22 | Day |
Last modified on
| 2023 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058908
