UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective study of evaluating the incidence and clinical outcomes of bioprosthetic aortic-valve thrombosis
Title of the study (Brief title)	The incidence and clinical outcomes of bioprosthetic aortic-valve thrombosis
Region	Japan

Condition
Condition	Aortic stenosis
Classification by specialty	Cardiology Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This prospective study was designed to evaluate the incidence, predictors, and clinical outcomes of bioprosthetic aortic-valve thrombosis with multimodality imaging
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Frequency of patients with bioprosthetic aortic-valve thrombosis
Key secondary outcomes	Frequency of valve functional abnormalities in patients with bioprosthetic aortic-valve thrombosis

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	1) Presence of transcatheter or surgical bioprosthetic aortic valve implanted at least 48 hours prior to enrollment 2) Written informed consent is taken
Key exclusion criteria	1) Reduced renal function (estimated glomerular filtration rate of <30 mL/[min1.73 m2] 2) Known allergy to iodinated contrast agents
Target sample size	300

Research contact person
Name of lead principal investigator	Kentaro Hayashida
Organization	Keio University School of Medicine
Division name	Cardiology
Address	35 Shinanomachi, Sinjyuku-ku, Tokyo, Japan
TEL	03-3353-1211
Email	k-hayashida@umin.ac.jp

Public contact
Name of contact person	Ryo Yanagisawa
Organization	Keio University School of Medicine
Division name	Cardiology
Address	35 Shinanomachi, Sinjyuku-ku, Tokyo, Japan
TEL	03-3353-1211
Homepage URL
Email	ryoyanagi0217@gmail.com

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Funding Source
Organization	Financial support: none
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	慶應義塾大学病院（東京都）

Other administrative information
Date of disclosure of the study information	2016 Year 09 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 01 Day
Anticipated trial start date	2016 Year 07 Month 04 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	All included patients undergo four-dimensional contrast-enhanced cardiac computed tomography (CT) and transthoracic echocardiography (TTE) after the procedure to evaluate the incidence of bioprosthetic aortic-valve thrombosis and valve function. Clinical follow-up is performed at 6 months and 1 year for the first year and annually thereafter along with CT and TTE analysis to clarify the clinical outcomes of thrombosis.

Management information
Registered date	2016 Year 09 Month 05 Day
Last modified on	2018 Year 12 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027567