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NCT Number: NCT07434674

Incidence of Long-TeRm Atrial Fibrillation After Acute Illness

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sulpizio Cardiovascular Center

La Jolla, California, 92037, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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).

Secondary outcomes

  1. Time to first documented AF by 6 months

    Time frame: 6 months

  2. Time to first documented AF episode lasting ≥ 5 minutes

    Time frame: 12 months

  3. Mean AF burden

    Time frame: 12 months

  4. Mean AF episode length

    Time frame: 12 months

  5. Change in use of oral anticoagulation and antiarrhythmic drugs

    Time frame: 12 months

  6. Quality of life scores (SF-36)

    Time frame: 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).

  7. Incidence of hospitalization

    Time frame: 12 months

  8. Change in medication use

    Time frame: 12 months

  9. Incidence of stroke

    Time frame: 12 months

  10. Incidence of death

    Time frame: 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Benjamin U Hoffman, MD, PhD

CONTACT

[email protected]

858-246-2016

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • Boston Scientific Corporation

Registry information

Official study title

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

Acronym: ILR-AF

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 25, 2026
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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