Recruiting

Long-Term ECG Monitoring

Sponsor:

UCLA

Code:

NCT07434674

Conditions

Atrial Fibrillation (AF)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Atrial Fibrillation (AF)

Study ID

NCT07434674

Start date

Nov 1, 2025

Status verified date

Feb, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

ILR

Primary outcome measure

  • Time to first documented event of AF by 12 months [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Benjamin U Hoffman, MD, PhD

858-246-2016b2hoffman@health.ucsd.edu

Locations

Sulpizio Cardiovascular Center

Recruiting

La Jolla, California, United States, 92037

More Information

Sponsor

University of California, San Diego

Last update posted

Feb 25, 2026

Last verified

Feb, 2026

Keywords

  • ILR
  • AF
  • AFIB
  • Paroxysmal AF
  • Lone AF

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2026-02-25.