Ablation, Atrial Fibrillation Paroxysmal, Atrial Fibrillation, Persistent, Cardiac Arrhythmia
Conditions
Keywords
atrial fibrillation, Holter monitor, cardiac arrhythmia, arrhythmia risk, syncope, shortness of breath, dizziness, palpitations, tachycardia, sinus pauses, Holter ECG recorder
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.
Interventions
DEVICEHolter 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.
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Episode-based AF detection performance metrics | 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. | 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. |
Countries
United States
Contacts
STUDY_DIRECTORKwangdeok Lee, PhD
Abbott
Outcome results
None listed