UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055187 |
|---|---|
| Receipt number | R000063053 |
| Scientific Title | Incidence and Electrical Characteristics of the Epicardial Connection Between the Pulmonary Veins and Adjacent Structures |
| Date of disclosure of the study information | 2024/08/07 |
| Last modified on | 2024/08/07 14:32:42 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Incidence and Electrical Characteristics of the Epicardial Connection Between the Pulmonary Veins and Adjacent Structures
Acronym
Incidence and Electrical Characteristics of the Epicardial Connection Between the Pulmonary Veins and Adjacent Structures
Scientific Title
Incidence and Electrical Characteristics of the Epicardial Connection Between the Pulmonary Veins and Adjacent Structures
Scientific Title:Acronym
Incidence and Electrical Characteristics of the Epicardial Connection Between the Pulmonary Veins and Adjacent Structures
Region
| Japan |
Condition
Condition
atrial fibrillation
Classification by specialty
| Medicine in general | Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we analyzed epicardial connection between the pulmonary veins and adjacent structures incidence and focused on their electrical characteristics.
Basic objectives2
Others
Basic objectives -Others
The presence of muscle bundles bridging the right pulmonary vein and right atrium on the epicardial side has been reported to be 21%. On the other hand, the presence of muscle bundles bridging the left pulmonary vein and left atrium on the epicardial side is also known, but there have been no reports examining the detailed frequency. We decided to analyze 100 consecutive cases of patients undergoing pulmonary vein isolation who were treated with high frequency and who were likely to be eligible for treatment.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of muscle bundles running along the adventitia
Key secondary outcomes
The incidence of atrial fibrillation recurrence depending on the presence or absence of muscle bundles running along the epicardial side
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The subjects were patients who underwent radiofrequency catheter ablation for atrial fibrillation at the relevant medical institution.
Key exclusion criteria
Patients who were in atrial fibrillation at the start of catheter ablation and did not return to sinus rhythm even after defibrillation.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiro |
| Middle name | |
| Last name | Yamasaki |
Organization
Unversity of Tsukuba
Division name
Department of Cardiology
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
029-853-3143
hyamasaki@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Hiro |
| Middle name | |
| Last name | Yamasaki |
Organization
Unversity of Tsukuba
Division name
Deparment of Cardiology
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
029-853-3143
Homepage URL
hyamasaki@md.tsukuba.ac.jp
Sponsor or person
Institute
Institute of Medicine, University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Institute of Medicine, 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
Tsukuba Clinical Resarch & Development Organization
Address
2-1-1 Amakubo, Tsukuba, Ibaraki, Japan
Tel
029-853-3914
chiken@un.tsukuba.ac.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
| 2024 | Year | 08 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
100
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study subjects were patients who underwent radiofrequency catheter ablation for atrial fibrillation at affiliated hospitals between April 1, 2018 and March 31, 2020. This was a cohort study that retrospectively evaluated patient information.
Management information
Registered date
| 2024 | Year | 08 | Month | 07 | Day |
Last modified on
| 2024 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063053
