Atrial Fibrillation (AF)
Conditions
Keywords
ILR, AF, AFIB, Paroxysmal AF, Lone AF
Brief summary
The investigators seek to conduct a prospective study to assess the recurrence of AF in patients with acute AF using a long-term ECG monitoring strategy with an insertable cardiac monitor (ICM), which is clinically indicated in this scenario as part of the standard of care. The investigators hypothesize that patients diagnosed with acute AF in the setting of cardiac surgery will have higher rates of AF recurrence than acute AF diagnosed in the setting of non-cardiac surgery or medical illness.
Interventions
None listed
Sponsors
University of California, San Diego
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient has an existing clinical indication for implantation of an insertable cardiac monitor (ICM) and will undergo ICM implantation as part of their standard medical care. 2. Patient is scheduled to receive or has received a Boston Scientific LUX-DX™ insertable cardiac monitor. 3. Episode of acute AF. Acute AF is defined as AF detected in an acute care setting or during an acute illness. Before enrollment, the following tests are minimally required as standard tests to establish the diagnosis of acute AF: * 12-lead ECG for AF detection * 24-h ECG or telemetry monitoring for AF detection and PAC analysis 4. Patient or legally authorized representative signs and dates the patient consent form. 5. Patient is ≥18 years old. 6. Patient is willing and able to comply with all study procedures and attend the required follow-up visits for the duration of the study.
Exclusion criteria
1. Patient has a known history of AF or atrial flutter prior to the index acute AF episode. 2. Patient has another indication for antiarrhythmic medications according to AHA/ACC/HRS guidelines, independent of the acute AF episode. 3. Patient has a permanent contraindication to oral anticoagulation (OAC) that, in the opinion of the treating physician, would preclude any future consideration of OAC for AF management. 4. Patient is currently enrolled in another clinical trial that will affect the objectives or endpoints of this study. 5. Patient's life expectancy is less than one year, as determined by the treating physician. 6. Patient is pregnant. 7. Patient has a current indication for implant with a cardiac implantable electronic device (CIED) such as a pacemaker or defibrillator, or an implantable hemodynamic monitoring system, as the study intervention would be redundant or potentially interfere with the clinical indication. 8. Patient is not fit, able, or willing to follow the required procedures of the Clinical Investigation Plan.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to first documented event of AF by 12 months | 12 months | The primary objective is to determine the time to first documented event of AF by 12 months of continuous rhythm monitoring, stratified by the setting of acute AF diagnosis (cardiac surgery, non-cardiac surgery, and medical illness). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to first documented AF by 6 months | 6 months | — |
| Time to first documented AF episode lasting ≥ 5 minutes | 12 months | — |
| Mean AF burden | 12 months | — |
| Mean AF episode length | 12 months | — |
| Change in use of oral anticoagulation and antiarrhythmic drugs | 12 months | — |
| Quality of life scores (SF-36) | 12 months | Change in Quality of Life scores as assessed by the Short Form 36 Health Survey (SF-36). The SF-36 is a 36-item, patient-reported survey assessing patient health across eight domains. The scores are weighted and summed to produce a value ranging from 0 to 100, where higher scores indicate a better quality of life (better health outcome). |
| Incidence of hospitalization | 12 months | — |
| Change in medication use | 12 months | — |
| Incidence of stroke | 12 months | — |
| Incidence of death | 12 months | — |
Countries
United States
Contacts
CONTACTBenjamin U Hoffman, MD, PhD
Outcome results
None listed