UMIN-CTR Clinical Trial

Basic information
Public title	Short-term and long-term safety and efficacy of leadless pacemaker
Acronym	Safety and efficacy of leadless pacemaker
Scientific Title	Short-term and long-term safety and efficacy of leadless pacemaker
Scientific Title:Acronym	Safety and efficacy of leadless pacemaker
Region	Japan

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

Objectives
Narrative objectives1	To evaluate safety and efficacy of leadless pacemaker and to identify the fluoroscopic predictors for capture threshold post-implant
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Electrical parameter and complication of short-term and long-term after leadless pacemaker.
Key secondary outcomes	Pre-deployment direction of the delivery catheter in the multiple fluoroscopic view and post deployment capture threshold at implantation.

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	Permanent pacing indication class I and IIa for bradycardia or conduction system disturbance.
Key exclusion criteria	age of less than 20 years-old
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Toshiaki Middle name Last name Sato
Organization	Kyorin University, Medical school
Division name	Division of Advanced Arrhythmia Management
Zip code	181-8611
Address	6-20-2 Shinkawa, Mitaka-City, Tokyo
TEL	0422-47-5511
Email	toshiaki_sato@ks.kyorin-u.ac.jp

Public contact
Name of contact person	1st name Toshiaki Middle name Last name Sato
Organization	Kyorin University, Medical school
Division name	Division of Advanced Arrhythmia Management
Zip code	181-8611
Address	6-20-2 Shinkawa, Mitaka
TEL	0422-47-5511
Homepage URL
Email	toshiaki_sato@ks.kyorin-u.ac.jp

Sponsor
Institute	Kyorin University, Medical school
Institute
Department

Funding Source
Organization	Kyorin University, Medical school
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	Faculty of Medicine Research Ethics Committee, Kyorin University
Address	6-20-2 Shinkawa, Mitaka
Tel	+81-422-47-5513
Email	ec@ks.kyorin-u.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	2021 Year 03 Month 02 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	2020 Year 04 Month 04 Day
Date of IRB	2020 Year 04 Month 04 Day
Anticipated trial start date	2020 Year 04 Month 04 Day
Last follow-up date	2025 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Single center observational study

Management information
Registered date	2021 Year 03 Month 02 Day
Last modified on	2021 Year 03 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049670