Long-term atrial fibrillation risk after an acute illness

Incidence of Long-TeRm Atrial Fibrillation After Acute Illness (ILR-AF)

A small implantable heart monitor will be used to see if adults who develop acute atrial fibrillation—especially after cardiac surgery—have more long-term recurrences than those with AF after non-cardiac surgery or medical illness.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of California, San Diego (Academic / other)
• Locations: 1 site (La Jolla, California)
• Trial ID: NCT07434674 on ClinicalTrials.gov

What this trial studies

This prospective observational project enrolls adults with acute AF who have a clinical indication for a Boston Scientific LUX-DX insertable cardiac monitor and will receive the device as part of routine care. Participants are grouped by the context of the index AF episode (cardiac surgery, non-cardiac surgery, or medical illness) and are monitored with continuous long-term ECG from the implantable monitor. Investigators will compare device-detected AF recurrence rates across those groups and collect clinical follow-up data at scheduled visits. The primary hypothesis is that AF occurring in the setting of cardiac surgery has higher recurrence rates than AF occurring with non-cardiac surgery or medical illness.

Who should consider this trial

Good fit: Adults (≥18) with an acute AF episode, no prior history of AF, a clinical indication for and planned implantation of a Boston Scientific LUX-DX insertable cardiac monitor, and ability to attend follow-up visits.

Not a fit: Patients with a known history of atrial fibrillation before the index episode, those who will not receive an insertable cardiac monitor, or those unable to attend site follow-up are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, results could help tailor how long patients are monitored after an acute AF episode and guide follow-up and anticoagulation decisions.

How similar studies have performed: Prior work with implantable cardiac monitors has shown improved detection of recurrent AF in settings like cryptogenic stroke and post-operative AF, but direct comparisons of recurrence by acute AF context (cardiac vs non-cardiac vs medical illness) are limited.

Eligibility criteria

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.

Where this trial is running

La Jolla, California

• Sulpizio Cardiovascular Center — La Jolla, California, United States (Recruiting)

Study contacts

• Study coordinator: Benjamin U Hoffman, MD, PhD

Conditions Atrial Fibrillation; ILR; AF; AFIB; Paroxysmal AF; Lone AF