UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033701 |
|---|---|
| Receipt number | R000038417 |
| Scientific Title | Effects of transcatheter aortic valve implantation and aortic valve replacement on cardiac repolarization |
| Date of disclosure of the study information | 2018/08/10 |
| Last modified on | 2021/07/19 12:16:22 |
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Basic information
Public title
Effects of transcatheter aortic valve implantation and aortic valve replacement on cardiac repolarization
Acronym
TAVI and AVR on cardiac repolarization
Scientific Title
Effects of transcatheter aortic valve implantation and aortic valve replacement on cardiac repolarization
Scientific Title:Acronym
TAVI and AVR on cardiac repolarization
Region
| Japan |
Condition
Condition
Aortic valve stenosis
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effects of transcatheter aortic valve implantation (TAVI) or surgical procedure on cardiac repolarization, we evaluate QT dispersion and T peak-T end on ECG.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We assess the QT dispersion and T peak T end before, immediately, 1 month, 3 months and 6 months after surgery.
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
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who were admitted to Dokkyo Medical University Hospital and underwent TAVI or AVR between April 2016 and March 2020.
Key exclusion criteria
Leads in which the end of the T wave could not be clearly detected were excluded.And patients with atrial fibrillation (af) were also excluded.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeki Yamaguchi |
Organization
Dokkyo Medical University
Division name
Department of Anesthesiology
Zip code
Address
880 Kitakobayashi, Mibu, Tochigi, Japan
TEL
0282-86-1111
shigeki@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshifumi Takasusuki |
Organization
Dokkyo Medical University
Division name
Department of Anesthesiology
Zip code
Address
880 Kitakobayashi, Mibu, Tochigi, Japan
TEL
0282-86-1111
Homepage URL
takasusu@dokkyomed.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Dokkyo Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 08 | Month | 10 | 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
Completed
Date of protocol fixation
| 2018 | Year | 08 | Month | 08 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 12 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This retrospective study includes patients with aortic stenosis who were admitted to Dokkyo Medical University Hospital and underwent TAVI or AVR between April 2016 and March 2020.
Management information
Registered date
| 2018 | Year | 08 | Month | 09 | Day |
Last modified on
| 2021 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038417
