Aveir LP Post Marketing Surveillance

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT2032250125

Enrollment

304

Registered

2025-05-23

Start date

2025-05-12

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with disease suitable for dual chamber or single chamber LP for atrial use

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion 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

Exclusion criteria: none

Design outcomes

Primary

Measure	Time frame
The primary endpoint of this PMS evaluates the 3-year Aveir DR LP system complication-free rate in de novo Aveir DR patients.	—

Contacts

Public ContactKozo Hanada

Abbott Medical Japan LLC

kozo.hanada@abbott.com+81-3-3524-1792

Outcome results