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

NCT06172699 | Active Not Recruiting FDA Device

• 1 other identifier: ABT-CIP-10468
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 11

Brief 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

Keywords

atrial fibrillation; Holter monitor; cardiac arrhythmia; arrhythmia risk; syncope; shortness of breath; dizziness; palpitations; tachycardia; sinus pauses; Holter ECG recorder

Outcome Measures

Primary Outcomes (1)

• Episode-based AF detection performance metrics

  Episode-based AF detection performance metrics of the Assert-IQTM ICM device compared to that of simultaneous Holter monitoring in 150 subjects who had received the Assert-IQTM ICM device as part of their standard of care.

  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.

Study Arms (1)

Subjects successfully implanted with an Abbott Assert-IQ ICM device

Holter monitoring in subjects successfully implanted with an Abbott Assert-IQ ICM device

Device: Holter monitoring in patients who have been successfully implanted with an Abbott Assert-IQ ICM device

Interventions

Holter monitoring in patients who have been successfully implanted with an Abbott Assert-IQ ICM device 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.

Subjects successfully implanted with an Abbott Assert-IQ ICM device

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who are diagnosed with symptomatic, drug-refractory paroxysmal or persistent AF, and are scheduled to receive an Assert-IQTM ICM device

You may qualify if:

• Have an approved indication AND are scheduled to receive an Assert-IQTM ICM device prior to enrollment in the study.
• Diagnosed with symptomatic, drug-refractory paroxysmal or persistent AF prior to enrollment in the study and scheduled to undergo a first-time atrial fibrillation ablation.
• Have a cellular phone or the ability or willing to use a mobile transmitter that is compatible with the myMerlin™ App and able to communicate with the Assert-IQTM ICM device. If a subject doesn't have a cell phone or loses their cell phone, then the site can provide a mobile transmitter to the subject. The study will not provide cell phones.
• Are 18 years of age or older, or of legal age to give informed consent specific to state and national law.
• Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations.

You may not qualify if:

• Subject is currently participating in another clinical investigation that could confound the results of this study, without documented pre-approval from Abbott.
• Subject is implanted with a cardiac implantable electronic device (CIED) with pacing capability.
• Have a life expectancy of less than 1 year due to any condition.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (11)

University of California at San Diego (UCSD) Medical Center

San Diego, California, 92103, United States

Location

Orlando Health

Orlando, Florida, 32806, United States

Location

Kansas City Cardiac Arrhythmia Research Foundation

Overland Park, Kansas, 66211, United States

Location

Trinity Health-Michigan d/b/a Michigan Heart

Ann Arbor, Michigan, 48106, United States

Location

St. Peter's Health Partners Medical Associates, PC

Albany, New York, 12205, United States

Location

Trident Medical Center

Charleston, South Carolina, 29406, United States

Location

Erlanger Medical Center

Chattanooga, Tennessee, 37403, United States

Location

Shannon Clinic

San Angelo, Texas, 76903, United States

Location

Methodist Texsan Hospital

San Antonio, Texas, 78201, United States

Location

Heart Rhythm Associates

The Woodlands, Texas, 77380, United States

Location

Aurora Medical Group

Milwaukee, Wisconsin, 53215, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac; Syncope; Dyspnea; Dizziness; Tachycardia

Interventions

Electrocardiography, Ambulatory

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Sensation Disorders; Cardiac Conduction System Disease

Intervention Hierarchy (Ancestors)

Electrocardiography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Monitoring, Ambulatory; Monitoring, Physiologic

Study Officials

• Kwangdeok Lee, PhD

  Abbott

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 15, 2023
• Study Start: January 1, 2024
• Primary Completion: December 24, 2024
• Study Completion: December 24, 2025
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)