NCT05252702

Aveir DR i2i Study

Aveir Dual-Chamber Leadless i2i IDE Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 464 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prospective, non-randomized, multi-center, international study designed to evaluate the safety and effectiveness of the Aveir™ Dual-Chamber (DR) Leadless Pacemaker system.

Detailed description

The purpose of this clinical investigation is to evaluate the clinical safety and effectiveness of the Aveir DR Leadless Pacemaker system in a patient population indicated for a DDD(R) pacemaker. Subjects participating in the study are followed through at least 12 months with data collected at baseline, implant procedure, pre (hospital) discharge, and follow-up at 1 month, 3 months, 6 months, 12 months, and every 6 months thereafter until study completion

Conditions

• Cardiac Pacemaker, Artificial
• Cardiac Rhythm Disorder
• Bradycardia

Interventions

Type	Name	Description
DEVICE	Aveir DR Leadless Pacemaker System	Patients will undergo a dual chamber leadless pacemaker system implant wherein a leadless pacemaker will be implanted in the right ventricle and right atrium

Timeline

• Start date: 2022-02-02
• Primary completion: 2023-08-02
• Completion: 2025-11-01
• First posted: 2022-02-23
• Last updated: 2025-08-15
• Results posted: 2024-11-05

Locations

78 sites across 13 countries: United States, Austria, Belgium, Canada, Czechia, France, Hong Kong, Italy, Japan, Netherlands, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated device study