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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033701
Receipt No. R000038417
Official scientific title of the study 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 2018/10/16

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Basic information
Official scientific title of the study Effects of transcatheter aortic valve implantation and aortic valve replacement on cardiac repolarization
Title of the study (Brief title) 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 Shigeki Yamaguchi
Organization Dokkyo Medical University
Division name Department of Anesthesiology
Address 880 Kitakobayashi, Mibu, Tochigi, Japan
TEL 0282-86-1111
Email shigeki@dokkyomed.ac.jp

Public contact
Name of contact person Toshifumi Takasusuki
Organization Dokkyo Medical University
Division name Department of Anesthesiology
Address 880 Kitakobayashi, Mibu, Tochigi, Japan
TEL 0282-86-1111
Homepage URL
Email takasusu@dokkyomed.ac.jp

Sponsor
Institute Department of Anesthesiology, Dokkyo Medical University
Institute
Department

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)

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

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 08 Month 08 Day
Anticipated trial start date
2018 Year 08 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
2018 Year 10 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038417

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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