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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000039647 |
Receipt No. | R000045219 |
Scientific Title | Prospective evaluation of efficacy of left bundle branch pacing in patients with bradycardia |
Date of disclosure of the study information | 2020/05/01 |
Last modified on | 2020/05/02 |
Basic information | ||
Public title | Coordinated strain and Response of Contraction by Left Bundle Branch Pacing Study | |
Acronym | CORRECT-LBB Study | |
Scientific Title | Prospective evaluation of efficacy of left bundle branch pacing in patients with bradycardia | |
Scientific Title:Acronym | CORRECT-LBB Study | |
Region |
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Condition | ||
Condition | Bradycardia | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | This study is aimed to identify the patients who benefit most from left bundle branch pacing. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Explanatory |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | Changes in maximum rate of left ventricular pressure (LV-dP/dtmax) and 2D-speckle tracking strain of left ventricle by left bundle branch pacing |
Key secondary 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 | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Among patients referred to Sapporo City General Hospital for permanent pacemaker implantation due to bradycardia, (1) those with a LVEF greater than 35% and left bundle branch block, (2) those with failure of His bundle pacing, are eligible. (3) Patients undergoing implantation of a cardiac resynchronization therapy (CRT) device, with lack of appropriate coronary sinus vein for a LV lead placement, are also eligible. | |||
Key exclusion criteria | Patients who are judged as inappropriate for the study by investigators are excluded. | |||
Target sample size | 15 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Sapporo City General Hospital | ||||||
Division name | Cardiovascular Medicine | ||||||
Zip code | 060-8604 | ||||||
Address | Kita-11, Nishi-13, Chuo-ku, Sapporo 060-8604, Japan | ||||||
TEL | 011-726-2211 | ||||||
hisashi.yokoshiki@doc.city.sapporo.jp |
Public contact | |||||||
Name of contact person |
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Organization | Sapporo City General Hospital | ||||||
Division name | Cardiovascular Medicine | ||||||
Zip code | 060-8604 | ||||||
Address | Kita-11, Nishi-13, Chuo-ku, Sapporo 060-8604, Japan | ||||||
TEL | 011-726-2211 | ||||||
Homepage URL | https://www.city.sapporo.jp/hospital/ | ||||||
masahiro-toba@doc.city.sapporo.jp |
Sponsor | |
Institute | Sapporo City General Hospital |
Institute | |
Department |
Funding Source | |
Organization | None |
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 | Sapporo City General Hospital Research Ethics Committee |
Address | Kita-11, Nishi-13, Chuo-ku, Sapporo 060-8604, Japan |
Tel | 011-726-2211 |
ryota.hayashi@city.sapporo.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 | 市立札幌病院 Sapporo City General Hospital |
Other administrative information | |||||||
Date of disclosure of the study information |
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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 |
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Anticipated trial start date |
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Last follow-up date |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
Other related information | Relation between optimal LV strain by left bundle branch pacing and electrocardiographic findings |
Management information | |||||||
Registered date |
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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=R000045219 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |