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Subjects successfully implanted with an Abbott Assert-IQ ICM device for Atrial Fibrillation (Assert-IQ Trial)
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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
Assert-IQ Trial 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
Assert-IQ Trial Timeline
Screening ~ 3 weeks3 visits
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.
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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Episode-based AF detection performance metrics
Assert-IQ 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
638 Previous Clinical Trials
404,038 Total Patients Enrolled
75 Trials studying Atrial Fibrillation
31,836 Patients Enrolled for Atrial Fibrillation
Kwangdeok Lee, PhDStudy DirectorAbbott
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