UMIN-CTR Clinical Trial

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
Email	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
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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