NCT07434674 · University of California, San Diego
Incidence of Long-TeRm Atrial Fibrillation After Acute Illness
(ILR-AF)
What this study is about
The investigators seek to conduct a forward-looking 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 the usual treatment.
View original scientific description
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.
Primary outcome measures
Time to first documented event of AF by 12 months
Time frame: 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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
- Patient is scheduled to receive or has received a Boston Scientific LUX-DX™ insertable cardiac monitor.
- 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
- Patient or legally authorized representative signs and dates the patient consent form.
- Patient is ≥18 years old.
- 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
- Patient has a known history of AF or atrial flutter prior to the index acute AF episode.
- Patient has another indication for antiarrhythmic medications according to AHA/ACC/HRS guidelines, independent of the acute AF episode.
- 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.
- Patient is currently enrolled in another clinical trial that will affect the objectives or endpoints of this study.
- Patient's life expectancy is less than one year, as determined by the treating physician.
- Patient is pregnant.
- 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.
- Patient is not fit, able, or willing to follow the required procedures of the Clinical Investigation Plan.
Where
- La Jolla, California
Collaborators
Boston Scientific Corporation
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 25, 2026 · Source of record for eligibility and locations