臨床研究等提出・公開システム

Date of registration	May. 23, 2025
Last modified on	May. 23, 2025
Trial ID	jRCT2032250125

Scientific Title	Aveir LP Post Marketing Surveillance
Public Title	Aveir LP Post Marketing Surveillance

Contact for Scientific Queries	Name	Stephanie Delgado
	Affiliation	Abbott
	Address	15900 Valley View Court, Sylmar, CA, 91342, US
	Telephone	1-818-4933285
	E-mail	stephanie.delgado1@abbott.com
Contact for Public Queries	Name	Hanada Kozo
	Affiliation	Abbott Medical Japan LLC
	Address	Hamarikyu Park Side Place 9F, 5-6-10 Tsukiji, Chuo-ku, Tokyo
	Telephone	+81-3-3524-1792
	E-mail	kozo.hanada@abbott.com

Recruitment status	Pending

Anticipated date of first enrollment		May. 12, 2025
Target sample size		304
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	Target patients should be selected in accordance with the device IFU, JCS/JHRS pacing guidelines and the JHRS Statement. All patients with an attempted dual-chamber Aveir DR or single-chamber atrial Aveir AR implant are expected to be approached regarding the PMS(Post Marketing Surveillance). The following patients who agree to participate in the surveillance upon signing an Informed Consent form, are indicated for dual-chamber or single-chamber atrial LPs, and have tried therapy with the Aveir LP will be registered: - Patients indicated for de novo dual-chamber LP's - Patients indicated for a de novo atrial LP - Upgrade Patients - Rollover patients from the Aveir DR i2i IDE study will participate in the surveillance upon their consent
	Exclusion Criteria	none
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Patients with disease suitable for dual chamber or single chamber LP for atrial use
Primary Outcome(s)		The primary endpoint of this PMS evaluates the 3-year Aveir DR LP system complication-free rate in de novo Aveir DR patients.

Primary Sponsor	Abbott Medical Japan LLC

Name of Certified Review Board	N/A due to Post Marketing Surveillance
Address	N/A, Tokyo

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none