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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name