UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical Significance of Injury Current Analysis after Permanent Leadless Cardiac Pacemaker Implantation
Title of the study (Brief title)	Clinical Significance of Injury Current Analysis after Permanent Leadless Cardiac Pacemaker Implantation
Region	Japan

Condition
Condition	Bradyarrhythmia
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine whether injury current on the intracardiac electrogram is correlated with adequate fixation in permanent leadless cardiac pacemaker implantation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To clarify the useful parameters of an injury current at the time of leadless pacemaker implantation for expecting future stable pacing and sensing thresholds.
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	1) Consecutive patients who underwent a leadless pacemaker implantation according to guideline-based indications for ventricular pacemaker implantation. 2) The patients who are able to follow up over 6 months.
Key exclusion criteria	1) Patients without a clinical indication for leadless pacemaker implantation. 2) Patients that had a past history with unstable angina or acute myocardial infarction or coronary revascularization within 30 days. 3) Patients who had a mechanical tricuspid valve replacement, or have a schedule to receive tricuspid valve repair or replacement. 4) The patients with life expectancy within 6 months. 5) Patients with pregnancy. 6) Patients who rejected the inclusion in this study.
Target sample size	50

Research contact person
Name of lead principal investigator	Masue Yoh
Organization	Kansai Medical University Medical Center
Division name	Division of Cardiology, Nephrology, and Endocrinology and Metabolism
Address	10-15 Fumizono-cho, Moriguchi, Osaka
TEL	(06)6992-1001
Email	yohm@mc.kmu.ac.jp

Public contact
Name of contact person	Masue Yoh
Organization	Kansai Medical University Medical Center
Division name	Division of Cardiology, Nephrology, and Endocrinology and Metabolism
Address	10-15 Fumizono-cho, Moriguchi, Osaka
TEL	(06)6992-1001
Homepage URL
Email	yohm@mc.kmu.ac.jp

Sponsor
Institute	Kansai Medical University Medical Center
Institute
Department

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)

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	関西医科大学総合医療センター（大阪府）/ Kansai Medical University Medical Center

Other administrative information
Date of disclosure of the study information	2018 Year 04 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 12 Month 10 Day
Anticipated trial start date	2018 Year 04 Month 01 Day
Last follow-up date	2022 Year 12 Month 31 Day
Date of closure to data entry	2023 Year 12 Month 31 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Prospective study. Patients who underwent implantation of the leadless cardiac pacemaker from approval to December 2022. We are planning to perform a blood test, analysis of intracardiac electrograms, telemetry findings, and a predicted battery life, orientation of pacemaker on chest X-ray.

Management information
Registered date	2018 Year 01 Month 10 Day
Last modified on	2018 Year 01 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035040