Clinical trial NCT06172699: Assert-IQ Implantable Cardiac Monitor (ICM) Post Market Study
Official title: Assert-IQ Insertable Cardiac Monitor Post Market Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
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
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2023-12-15
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Episode-based AF detection performance metrics
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California at San Diego (UCSD) Medical Center
state: California
city: Orlando
country: United States
facility: Orlando Health
state: Florida
city: Overland Park
country: United States
facility: Kansas City Cardiac Arrhythmia Research Foundation
state: Kansas
city: Ann Arbor
country: United States
facility: Trinity Health-Michigan d/b/a Michigan Heart
state: Michigan
city: Albany
country: United States
facility: St. Peter's Health Partners Medical Associates, PC
state: New York
city: Charleston
country: United States
facility: Trident Medical Center
state: South Carolina
city: Chattanooga
country: United States
facility: Erlanger Medical Center
state: Tennessee
city: San Angelo
country: United States
facility: Shannon Clinic
state: Texas
city: San Antonio
country: United States
facility: Methodist Texsan Hospital
state: Texas
city: The Woodlands
country: United States
facility: Heart Rhythm Associates
state: Texas
city: Milwaukee
country: United States
facility: Aurora Medical Group
state: Wisconsin
Study officials:
affiliation: Abbott
name: Kwangdeok Lee, PhD
role: STUDY_DIRECTOR
References: