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

Cardiac Arrhythmia Clinical Trial

— Assert-IQ  

Official title:

Assert-IQ Insertable Cardiac Monitor Post Market Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06172699
• Other study ID #: ABT-CIP-10468
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: September 30, 2025

Study information

• Verified date: May 2024
• Source: Abbott Medical Devices
• Contact: Anuja Kulkarni, MPH
• Phone: 818-809-6754
• Email: anuja.kulkarni[@]abbott.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 30, 2025
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

Patients must meet ALL study inclusion criteria to participate in the study.

1. Have an approved indication AND are scheduled to receive an Assert-IQTM ICM device prior to enrollment in the study.

2. 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.

3. 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.

4. Are 18 years of age or older, or of legal age to give informed consent specific to state and national law.

5. 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.

Exclusion Criteria:

If ANY study exclusion criteria are met, the patient is excluded from the study and cannot be enrolled (recruitment failure).

1. Subject is currently participating in another clinical investigation that could confound the results of this study, without documented pre-approval from Abbott.

2. Subject is implanted with a cardiac implantable electronic device (CIED) with pacing capability.

3. Have a life expectancy of less than 1 year due to any condition.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	St. Peter's Health Partners Medical Associates, PC	Albany	New York
United States	Trinity Health-Michigan d/b/a Michigan Heart	Ann Arbor	Michigan
United States	Trident Medical Center	Charleston	South Carolina
United States	Erlanger Medical Center	Chattanooga	Tennessee
United States	Aurora Medical Group	Milwaukee	Wisconsin
United States	Orlando Health	Orlando	Florida
United States	Kansas City Cardiac Arrhythmia Research Foundation	Overland Park	Kansas
United States	Methodist Texsan Hospital	San Antonio	Texas
United States	University of California at San Diego (UCSD) Medical Center	San Diego	California
United States	Heart Rhythm Associates	The Woodlands	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.