臨床研究等提出・公開システム

Date of registration	June. 28, 2023
Last modified on	May. 01, 2026
Trial ID	jRCT2002230001

Scientific Title	Harmony Transcatheter Pulmonary Valve Use-Results Surveillance
Public Title	Harmony Transcatheter Pulmonary Valve Use-Results Surveillance

Contact for Scientific Queries	Name	Umetsu Aki
	Affiliation	Medtronic Japan
	Address	Shinagawa Season Terrace, 1-2-70 Konan, Minato-ku, Tokyo
	Telephone	+81-3-6776-1154
	E-mail	aki.umetsu@medtronic.com
Contact for Public Queries	Name	Umetsu Aki
	Affiliation	Medtronic Japan
	Address	Shinagawa Season Terrace, 1-2-70 Konan, Minato-ku, Tokyo
	Telephone	+81-3-6776-1154
	E-mail	aki.umetsu@medtronic.com

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Mar. 02, 2023
Actual date of first enrollment		Mar. 02, 2023
Target sample size		42
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	The Product is for use in patients with severe pulmonary regurgitation who have previously undergone surgical repair or transcatheter intervention (balloon valvuloplasty) to the right ventricular outflow tract, and are in clinical need of a pulmonary valve replacement. However, it is intended for use in patients for whom surgical procedures pose a high risk, and for whom the Product is deemed to be the optimal treatment. Note that this product should not be used for patients who have an artificial valve or a right ventricle to pulmonary artery conduit implanted.
	Exclusion Criteria	none
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		severe pulmonary regurgitation
Primary Outcome(s)		1) Proportion of patients with favorable hemodynamic function without valve reintervention at 1 year after the initial procedure 2) Procedure success rate at 30 days after the initial procedure 3) Device success rate up to 5 years after theinitial procedure 4) RVOT re-operation rate attributable to the Product up to 5 years after theinitial procedure 5) Re-interventation rate for the product up to 5 years after the initial procedure 6) Incidence of valve dysfunction up to 5 years after the initial procedure 7) Death due to any cause up to 5 years after the initial procedure 8) Adverse events and defects for which a causal relationship with the procedure or the Product cannot be ruled out (up to 5 years after the initial procedure)

Primary Sponsor	Medtronic Japan

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	N/A due to Post Marketing Surveillance
Address	N/A
Date of approval	April. 22, 2023

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	May. 01, 2026	(this page)	Changes
3	April. 28, 2026	Detail	Changes
2	Jan. 18, 2024	Detail	Changes
1	June. 28, 2023	Detail

List of change history