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Subjects successfully implanted with an Abbott Assert-IQ ICM device for Atrial Fibrillation (Assert-IQ Trial)

N/A
Recruiting
Research Sponsored by Abbott Medical Devices
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up holter monitor worn by the subjects over a minimum 72-hour and up to 7 days period. an af episode is defined as af has greater or equal to 2 minutes (≥2 minutes) in duration.
Awards & highlights

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.

Eligible Conditions
  • Atrial Fibrillation
  • Arrhythmia
  • Ablation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~holter monitor worn by the subjects over a minimum 72-hour and up to 7 days period. an af episode is defined as af has greater or equal to 2 minutes (≥2 minutes) in duration.
This trial's timeline: 3 weeks for screening, Varies for treatment, and holter monitor worn by the subjects over a minimum 72-hour and up to 7 days period. an af episode is defined as af has greater or equal to 2 minutes (≥2 minutes) in duration. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Episode-based AF detection performance metrics

Trial Design

1Treatment groups
Experimental Treatment
Group I: Subjects successfully implanted with an Abbott Assert-IQ ICM deviceExperimental Treatment1 Intervention
Holter monitoring in subjects successfully implanted with an Abbott Assert-IQ ICM device

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Who is running the clinical trial?

Abbott Medical DevicesLead Sponsor
647 Previous Clinical Trials
408,384 Total Patients Enrolled
76 Trials studying Atrial Fibrillation
31,890 Patients Enrolled for Atrial Fibrillation
Kwangdeok Lee, PhDStudy DirectorAbbott
~17 spots leftby Oct 2024
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