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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000040622 |
Receipt No. | R000046352 |
Scientific Title | Efficacy of physiological pacing in patients with bradycardia and/or conduction system disturbance |
Date of disclosure of the study information | 2020/06/02 |
Last modified on | 2020/06/02 |
Basic information | ||
Public title | Efficacy of physiological pacing in patients with bradycardia and/or conduction system disturbance | |
Acronym | Efficacy of physiological pacing | |
Scientific Title | Efficacy of physiological pacing in patients with bradycardia and/or conduction system disturbance | |
Scientific Title:Acronym | Efficacy of physiological pacing | |
Region |
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Condition | ||
Condition | Bradycardia and/or conduction system disturbance | |
Classification by specialty |
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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 | Others |
Basic objectives -Others | 1) To determine predictors for successful capture of left bundle branch. 2) To compare the electrical propagation in the conduction system and ventricle between the His-bundle pacing and left bundle branch area pacing. 3) To estimate the efficacy for the cardiac function. |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Explanatory |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | Successful implantation of physiological left bundle branch area pacing lead and complications during one year |
Key secondary outcomes | 1) Predictors for successful capture of left bundle branch. 2) Eelectrical propagation in the conduction system and ventricle between the His-bundle pacing and left bundle branch area pacing. 3) Cardiac function of left bundle branch area pacing. |
Base | |
Study type | Observational |
Study design | |
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Randomization | |
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Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
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Eligibility | ||||
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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 | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kyorin University,Medical school | ||||||
Division name | Division of Advanced Arrhythmia Management | ||||||
Zip code | 181-8611 | ||||||
Address | 6-20-2 Shinkawa, Mitaka | ||||||
TEL | +81-422-47-5511 | ||||||
toshiaki_sato@ks.kyorin-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Kyorin University,Medical school | ||||||
Division name | Division of Advanced Arrhythmia Management | ||||||
Zip code | 181-8611 | ||||||
Address | 6-20-2 Shinkawa, Mitaka | ||||||
TEL | +81-422-47-5511 | ||||||
Homepage URL | |||||||
toshiaki_sato@ks.kyorin-u.ac.jp |
Sponsor | |
Institute | Kyorin University |
Institute | |
Department |
Funding Source | |
Organization | Kyorin University |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
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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 |
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 |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Number of participants that the trial has enrolled | |
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Baseline Characteristics | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Enrolling by invitation | ||||||
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Other | |
Other related information | Single center observational study |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046352 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |