臨床研究等提出・公開システム

Scientific Title	N/A (N/A)
Public Title	N/A

Contact for Scientific Queries	Name	Koichiro Kinugawa
	Affiliation	Toyama University Hospital
	Address	2630 Sugitani,Toyama-shi,Toyama,Japan
	Telephone	+81-76-434-2315
	E-mail	kinugawa0422@gmail.com
Contact for Public Queries	Name	Okamoto Etsuro
	Affiliation	Abbott Medical Japan
	Address	1-5-2 Higashi Shimbashi, Minato
	Telephone	+81-76-434-2315
	E-mail	etsuro.okamoto@abbott.com

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Mar. 02, 2026
Actual date of first enrollment		Mar. 02, 2026
Target sample size		250
Study Type		Interventional
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	1)The patient must be eligible to receive the TriClip System per the current approved indications for use, and 2)The patient must provide written informed consent prior to conducting any investigation-specific procedures not considered standard of care. If informed consent is not obtained, the subject is excluded from the post-approval study (recruitment failure).
	Exclusion Criteria	NA
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		symptomatic severe tricuspid regurgitation
Intervention(s)		Interventional tricuspid valve repair
Health Condition(s) Keyword		TR
Intervention(s) Keyword		TriClip
Health Condition(s) Code		D014262
Primary Outcome(s)		(1) Moderate or less TR at 30-day visit. (2) Single leaflet device attachment (SLDA) at 30-day visit.
Secondary Outcome(s)		NA

Primary Sponsor	Abbott Medical Japan

Source of Monetary Support / Secondary Sponsor	Abbott Medical Japan

Secondary Sponsor

Name of Certified Review Board	The National Cardiovascular Research Center IRB
Address	6-1 Shinmachi Kishibe, Suita, Osaka, Osaka
Telephone	+81-570-012-545
Date of approval	Dec. 22, 2025

Plan to share IPD	No

Countries of Recruitment（Except Japan）	None

History of Changes

No	Publication date
2	Sept. 10, 2026	(this page)	Changes
1	April. 14, 2026	Detail

List of change history