UMIN-CTR Clinical Trial

Basic information
Public title	A retrospective observational study investigating the change of transvalvular peak velocity among patients undergoing aortic valve replacement with bioprosthetic valve.
Acronym	AVR TEE study
Scientific Title	A retrospective observational study investigating the change of transvalvular peak velocity among patients undergoing aortic valve replacement with bioprosthetic valve.
Scientific Title:Acronym	AVR TEE study
Region	Japan

Condition
Condition	Patients undergoing aortic valve replacement with bioprosthetic valve.
Classification by specialty	Cardiology Surgery in general Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Aortic valve replacement (AVR) is an established procedure for treating aortic valvular diseases. Prosthesis-patient mismatch(PPM)is known as the factor increasing the postoperative mortality and morbidity. If intraoperative measurement of transvalvular peak velocity could predict postoperative PPM, intraoperative diagnosis and additional intervention may prevent postoperative PPM.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The interactions between time series variation of an adjusted peak trans-prosthetic valvular velocity and an intraoperative peak trans-prosthetic valvular velocity.
Key secondary outcomes	The interaction between time series variation of an adjusted peak trans-prosthetic valvular velocity and an implanted bio-prosthetic valve size, or a type of the implanted bio-prosthetic valve.

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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patient undergoing aortic valve replacement with bioprosthetic valve.
Key exclusion criteria	none
Target sample size	700

Research contact person
Name of lead principal investigator	1st name Kimito Middle name Last name Minami
Organization	National Cerebral and Cardiovascular Center
Division name	Department of Surgical Intensive Care
Zip code	565-8565
Address	5-7-1 Fujishirodai, Suita, Osaka, Japan
TEL	06-6833-5012
Email	nann_5115@ybb.ne.jp

Public contact
Name of contact person	1st name Kimito Middle name Last name Minami
Organization	National Cerebral and Cardiovascular Center
Division name	Department of Surgical Intensive Care
Zip code	565-8565
Address	5-7-1 Fujishirodai, Suita, Osaka, Japan
TEL	06-6833-5012
Homepage URL
Email	nann_5115@ybb.ne.jp

Sponsor
Institute	National Cerebral and Cardiovascular Center
Institute
Department

Funding Source
Organization	National Cerebral and Cardiovascular Center
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	National Cerebral and Cardiovascular Center
Address	5-7-1 Fujishirodai, Suita, Osaka, Japan
Tel	06-6833-5012
Email	k.minami@ncvc.go.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

Other administrative information
Date of disclosure of the study information	2018 Year 05 Month 01 Day

Related information
URL releasing protocol	https://www.jcvaonline.com/article/S1053-0770(19)30512-9/fulltext
Publication of results	Published

Result
URL related to results and publications	https://www.jcvaonline.com/article/S1053-0770(19)30512-9/fulltext
Number of participants that the trial has enrolled	556
Results	A multivariable logistic regression model was used to identify the predictors of patient-prosthesis mismatch at 1 year. There was no significant association between intraoperative peak velocity and peak velocity at 1 month (p = 0.419) or 1 year (p = 0.115). The implanted valve type (p < 0.001) and size (p < 0.001), but not intraoperative peak velocity (p = 0.503), were independent predictors of patient-prosthesis mismatch.
Results date posted	2019 Year 10 Month 04 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	The study comprised 556 patients who underwent aortic valve replacement with a bioprosthetic valve.
Participant flow	Retrospectively reviewed from clinical record.
Adverse events	None.
Outcome measures	The associations between peak velocity values at the aforementioned 3 time points were analyzed using a multivariable nonlinear regression model. A multivariable logistic regression model was used to identify the predictors of patient-prosthesis mismatch at 1 year.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2018 Year 04 Month 03 Day
Date of IRB	2018 Year 05 Month 28 Day
Anticipated trial start date	2018 Year 05 Month 28 Day
Last follow-up date	2018 Year 05 Month 28 Day
Date of closure to data entry	2018 Year 05 Month 28 Day
Date trial data considered complete	2018 Year 05 Month 28 Day
Date analysis concluded	2019 Year 03 Month 31 Day

Other

Other related information

Intraoperative trans-prosthetic valvular peak velocity, postoperative trans-prosthetic valvular peak velocity were extracted from medical record. Trans-prosthetic valvular peak velocity were adjusted for age, sex, body surface area, size of implanted bio-prosthetic valve, type of implanted bio-prosthetic valve, presence or absence of aortic insufficiency, morphology of aortic valve (tricuspid or bicuspid valve), and preoperative stroke volume. The interaction between time-series variation of peak trans-prosthetic valvular velocity and intraoperative peak trans-prosthetic valvular velocity was assessed using a linear regression model adjusted by the Huber-White method for repeated measures data.

Management information
Registered date	2018 Year 04 Month 03 Day
Last modified on	2021 Year 06 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036603