臨床研究等提出・公開システム

Japanese

Date of registration	April. 24, 2024
Last modified on	April. 24, 2024
Trial ID	jRCT1032240045

Scientific Title	VISTA Study (Navitor Post-Market Clinical Follow Up Study) (VISTA) (Post-Market Clinical Follow Up Study With Navitor Valve VISTA)
Public Title	VISTA Post-Market Clinical Study

Contact for Scientific Queries	Name	Masumoto Naohiro
	Affiliation	Abbott Medical Japan
	Address	Hamarikyu Park Side Place 9F, 5-6-10 Tsukiji, Chu o-ku, Tokyo 104-0045 Japan
	Telephone	+81-3-3524-1792
	E-mail	naohiro.masumoto@abbott.com
Contact for Public Queries	Name	Masumoto Naohiro
	Affiliation	Abbott Medical Japan
	Address	Hamarikyu Park Side Place 9F, 5-6-10 Tsukiji, Chuo-ku, Tokyo 104-0045 Japan
	Telephone	+81-3-3524-1792
	E-mail	naohiro.masumoto@abbott.com

Recruitment status	Pending

Anticipated date of first enrollment		May. 01, 2024
Actual date of first enrollment		Sept. 29, 2023
Target sample size		81
Study Type		Observational
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	- The patient is scheduled to undergo a Navitor TAVI procedure. - The patient has been informed of the nature of the study, agrees to its provisions,and has provided written informed consent as approved by the IRB (InvestigationalReview Board)/EC (Ethics Committee) of the respe ctive clinical site. - The patient and the treating physician agree that the subject will return for all required post procedure follow up visits.
	Exclusion Criteria	Life expectancy < 12 months from the time of informed consent due to non-cardiac co-morbid conditions. - In the judgment of the Investigator, patient presents with a medical, social, or psychological condition that could limit the ability or willingness to participate in the study, comply with study required testing and/or follow-up visits or that could impact scientific integrity of the study. - Known contraindication for computed tomography (CT) or sensitivity to contrast media, which cannot be adequately premedicated. - Inability to tolerate antiplatelet/anticoagulation therapy or nitinol alloy (nickel and titanium), which cannot be adequately premedicated. - Currently participating in an investigational drug or device study that may confound the results of this study
	Age Minimum	18age old over
	Age Maximum	100age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Aortic Stenosis
Intervention(s)
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code		D001024
Intervention(s) Code
Primary Outcome(s)		Moderate or greater paravalvular leak at 30 days post-TAVI procedure [Time Frame: 30 days post ind ex procedure] All-cause mortality at 30 days post-TAVI procedure [Time Frame: 30 days post index procedure]
Secondary Outcome(s)

Primary Sponsor	Abbott Medical Japan

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Kitamachi Clinic Ethics Committee
Address	1-1-3 Kichijoji Kitamachi, Musashino-shi, Tokyo, Tokyo
Telephone	+81-3-6779-8116
E-Mail	chi-pr-ec-kitamachi@cmicgroup.com
Approval Status	Approval
Date of approval	Nov. 15, 2023

Plan to share IPD	No
Plan description

Secondary ID(s)	NCT06008080
Issuing Authority	ClinicalTrials.gov

Countries of Recruitment（Except Japan）	France/Germany/Italy/Portugal/Spain/Swwitzerland/UK/Canada/Australia