UMIN-CTR Clinical Trial

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
Email	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
Email	ajitaro910@gmail.com

Sponsor
Institute	Hamamatsu University School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052216