UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052988 |
|---|---|
| Receipt number | R000060450 |
| Scientific Title | Assessment of tachycardia circuits of atrioventricular nodal reentrant tachycardia (retrospective study) |
| Date of disclosure of the study information | 2023/12/07 |
| Last modified on | 2024/06/05 22:55:03 |
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Basic information
Public title
Circuits of atrioventricular nodal reentrant tachycardia
Acronym
Circuits of AVNRT
Scientific Title
Assessment of tachycardia circuits of atrioventricular nodal reentrant tachycardia (retrospective study)
Scientific Title:Acronym
Circuits of AVNRT
Region
| Japan |
Condition
Condition
atrioventricular nodal reentrant tachycardia (AVNRT)
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal the reentrant circuit of AVNRT and to further evaluate the characteristics of the retrograde slow pathway (SP).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Identification of the retrograde SP using electroanatomical 3D mapping during atypical AVNRT or ventricular pacing in electrophisiology study.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All patients who underwent an EP study and catheter ablation for atypical AVNRT at our institution were retrospectively identified and included in the study.
Key exclusion criteria
The patients in whom retrograde atrial activation sequence during atypical AVNRT or ventricular pacing was not assessed using 3D mapping.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Mihoko |
| Middle name | |
| Last name | Kawabata |
Organization
AOI Universal Hospital
Division name
Department of Cardiovascular Disease
Zip code
210-0822
Address
2-9-1, Tamachi, Kawasaki-ku, Kawasaki-City, Kanagawa
TEL
0442775511
mihoko_kawabata@hotmail.com
Public contact
Name of contact person
| 1st name | Mihoko |
| Middle name | |
| Last name | Kawabata |
Organization
AOI Universal Hospital
Division name
Department of Cardiovascular Disease
Zip code
210-0822
Address
2-9-1, Tamachi, Kawasaki-ku, Kawasaki-City, Kanagawa
TEL
0442775511
Homepage URL
mihoko_kawabata@hotmail.com
Sponsor or person
Institute
AOI Universal Hospital
Institute
Department
Personal name
Kenzo Hirao
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
AOI universal hospital
Address
2-9-1, Tamachi, Kawasaki-ku, Kawasaki
Tel
0442775511
mihoko_kawabata@hotmail.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 | 12 | Month | 07 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 12 | Month | 04 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 05 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 07 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 12 | Month | 31 | Day |
Other
Other related information
The retrograde atrial activation sequence during atypical AVNRT or ventricular pacing was determined by both intracardiac electrograms and 3D mapping with particular attention paid to the CS ostium, tricuspid valve, and His bundle areas. The extent of the region where the His potential was recordable was demarcated1. The distance between 2 points was measured on the 3D map. When measuring distances from the CS ostium, the most inferior point (floor) of the CS ostium rim was used as the reference point.
Management information
Registered date
| 2023 | Year | 12 | Month | 04 | Day |
Last modified on
| 2024 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060450
