UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035117 |
|---|---|
| Receipt number | R000039159 |
| Scientific Title | Impact of the leadless pacemaker position on paced QRS morphology and prognosis: 3 dimensional analysis with cardiac computed tomography (MICRA-CT registry) |
| Date of disclosure of the study information | 2018/12/03 |
| Last modified on | 2019/07/05 10:38:08 |
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Basic information
Public title
Impact of the leadless pacemaker position on paced QRS morphology and prognosis: 3 dimensional analysis with cardiac computed tomography (MICRA-CT registry)
Acronym
MICRA-CT registry
Scientific Title
Impact of the leadless pacemaker position on paced QRS morphology and prognosis: 3 dimensional analysis with cardiac computed tomography (MICRA-CT registry)
Scientific Title:Acronym
MICRA-CT registry
Region
| Japan |
Condition
Condition
Sick sinus syndrome; complete atrioventricular block; atrial fibrillation with bradycardia
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A prolonged QRS duration is associated with increased congestive heart failure risk, sudden cardiac death, and impaired left ventricular function. Right ventricle (RV) pacing prolongs the surface electrocardiogram (ECG) QRS duration variably depending on the lead position. However, this has not been evaluated with the leadless pacemaker (LLPM, Micra Transcatheter Pacing System) to date. The purpose of the present study is to evaluate the impact of pacemaker position on QRS morphology and its prognosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between leadless pacemaker position and QRS morphology
Key secondary outcomes
Relationship between leadless pacemaker position and clinical 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
| 60 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
all consecutive cases undergoing leadless pacemaker implantation
Key exclusion criteria
nothing
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yoshiharu |
| Middle name | |
| Last name | Higuchi |
Organization
Osaka Police Hospital
Division name
Cardiology
Zip code
543-0035
Address
10-31 Kitayamacho Tennojiku, Osaka city, Osaka, Japan
TEL
06-6771-6051
yhiguchi-ja@umin.net
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Sotomi |
Organization
Osaka Police Hospital
Division name
Cardiology
Zip code
543-0035
Address
10-31 Kitayamacho Tennojiku, Osaka city, Osaka, Japan
TEL
06-6771-6051
Homepage URL
sotomiyohei@gmail.com
Sponsor or person
Institute
Osaka Police Hospital
Institute
Department
Personal name
Funding Source
Organization
nothing
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
Osaka Police Hospital
Address
10-31 Kitayamacho Tennojiku, Osaka city, Osaka, Japan
Tel
0667716051
yhiguchi-ja@umin.net
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
| 2018 | Year | 12 | Month | 03 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 13 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None.
Management information
Registered date
| 2018 | Year | 12 | Month | 03 | Day |
Last modified on
| 2019 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039159
