NCT06172699

Assert-IQ Implantable Cardiac Monitor (ICM) Post Market Study

Assert-IQ Insertable Cardiac Monitor Post Market Study

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, non-randomized, multi-center, real-world post-market study to collect and evaluate data regarding the performance of the enhanced atrial fibrillation detection algorithm of the Assert-IQTM Implantable Cardiac Monitor (ICM) device.

Detailed description

The study's intent is to generate long-term real-world data on the safety, performance, and clinical benefits of the Assert-IQTM ICM device system. This clinical investigation is sponsored by Abbott Medical.

Conditions

• Atrial Fibrillation Paroxysmal
• Atrial Fibrillation, Persistent
• Cardiac Arrhythmia
• Ablation

Interventions

Type	Name	Description
DEVICE	Holter monitoring in patients who have been successfully implanted with an Abbott Assert-IQ ICM device	All enrolled subjects who meet eligibility criteria will undergo an attempted implant within 30 days of consent. After successful device implant, subjects will be followed at 1 and 12 months. Subjects will be fitted with a Holter monitor during the 1m follow-up visit and will complete a minimum of 72 hours and maximum of up to 7 days of Holter monitoring.

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-12-24
• Completion: 2025-12-24
• First posted: 2023-12-15
• Last updated: 2025-02-20

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated device study