UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043493
Receipt number R000049668
Scientific Title Efficacy of physiological left bundle branch area pacing in patients with bradycardia and heart failure
Date of disclosure of the study information 2021/03/04
Last modified on 2021/03/02 12:43:38

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Basic information

Public title

Efficacy of physiological left bundle branch area pacing in patients with bradycardia and heart failure

Acronym

Efficacy of physiological left bundle branch area pacing

Scientific Title

Efficacy of physiological left bundle branch area pacing in patients with bradycardia and heart failure

Scientific Title:Acronym

Efficacy of physiological left bundle branch area pacing

Region

Japan


Condition

Condition

To investigate the efficacy and complication of the physiological left bundle branch area pacing

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the efficacy and complication of the physiological left bundle branch area pacing

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Successful implantation of physiological left bundle branch area pacing lead and complications during more than six months

Key secondary outcomes

1)Comparison of electrical propagation in the conduction system and ventricle between the His-bundle pacing and left bundle branch area pacing. 2) Identification of predictors for successful implantation of left bundle branch area pacing lead. 3) Cardiac function during left bundle branch area pacing.


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) Permanent pacing indication class I and IIa for bradycardia or conduction system disturbance.
2) Cardiac resynchronization therapy indication class IIa in patients with atrioventricular block, left ventricular ejection fraction of 36-50% and pacing dependency.
3) Cardiac resynchronization therapy indication class I- IIa in patients with left ventricular ejection fraction of <36% and failure of left ventricle pacing and non-responder for cardiac resynchronization therapy

Key exclusion criteria

age of less than 20 years-old

Target sample size

100


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 or person

Institute

Kyorin University

Institute

Department

Personal name



Funding Source

Organization

Kyorin University

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

Faculty of Medicine Research Ethics Committee, Kyorin University

Address

6-20-2 Shinkawa, Mitaka-City, Tokyo

Tel

+81-422-47-5513

Email

rec@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 04 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

2019 Year 11 Month 01 Day

Date of IRB

2019 Year 11 Month 01 Day

Anticipated trial start date

2019 Year 11 Month 01 Day

Last follow-up date

2024 Year 10 Month 31 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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049668


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name