MedTrace Logo

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

NCT06172699 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 151

Last updated 2026-05-13

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Kwangdeok Lee, PhD · Abbott

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2024-12-24
Completion
2025-11-10
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06172699 on ClinicalTrials.gov