UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045741 |
|---|---|
| Receipt number | R000052216 |
| Scientific Title | A new method for right ventricular lead implantation into the intraventricular septum: Individualized left anterior oblique projection assessed using the preprocedural electrocardiographic QRS axis |
| Date of disclosure of the study information | 2021/10/14 |
| Last modified on | 2021/10/14 13:38:06 |
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Basic information
Public title
A new method for right ventricular lead implantation into the intraventricular septum: Individualized left anterior oblique projection assessed using the preprocedural electrocardiographic QRS axis
Acronym
A new method for right ventricular lead implantation into the intraventricular septum: Individualized left anterior oblique projection assessed using the preprocedural electrocardiographic QRS axis
Scientific Title
A new method for right ventricular lead implantation into the intraventricular septum: Individualized left anterior oblique projection assessed using the preprocedural electrocardiographic QRS axis
Scientific Title:Acronym
A new method for right ventricular lead implantation into the intraventricular septum: Individualized left anterior oblique projection assessed using the preprocedural electrocardiographic QRS axis
Region
| Japan |
Condition
Condition
complete atrioventricular block, advanced atrioventricular block, sick sinus syndrome, and/or brady-atrial fibrillation
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Whether it is possible to obtain individualized LAO by preprocedural electrocardiographic parameters and, if so, whether these parameters can help to improve the success rate of RV lead implantation into the RV septum.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Success rate of placement in the interventricular septum
Key secondary outcomes
Changes in pro-BNP levels before and after surgery
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
complete atrioventricular block, advanced atrioventricular block, sick sinus syndrome, and/or brady-atrial fibrillation to implant a pacemaker
Key exclusion criteria
Patients with complete atrioventricular block with an infra-Hisian escape beat who have not undergone an electrocardiogram before the onset of atrioventricular block
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Taro |
| Middle name | |
| Last name | Narumi |
Organization
Hamamatsu University School of Medicine
Division name
Department of Cardiology
Zip code
431-3192
Address
Handayama, Higashi Ward, Hamamatsu
TEL
+81534352356
ajitaro910@gmail.com
Public contact
Name of contact person
| 1st name | Taro |
| Middle name | |
| Last name | Narumi |
Organization
Hamamatsu University School of Medicine
Division name
Department of Cardiology
Zip code
431-3192
Address
Handayama, Higashi Ward, Hamamatsu
TEL
+81534352356
Homepage URL
ajitaro910@gmail.com
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine
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
Hamamatsu University School of Medicine
Address
1-20-1, Handayama, Higashi-ward, Hamamatsu
Tel
+81534352550
crmanager@hama-med.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
浜松医科大学付属病院 (静岡県)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 14 | 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
69
Results
The success rate for placing the RV lead into the interventricular septum was significantly improved in the internal validation cohort group (93% vs. 64%, P < 0.05). In addition, the N-terminal pro-brain natriuretic peptide level decreased significantly after surgery in the interventricular septal indwelling group.
Results date posted
| 2021 | Year | 10 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
none
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 30 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
retrospective study
Management information
Registered date
| 2021 | Year | 10 | Month | 13 | Day |
Last modified on
| 2021 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052216
