Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
study ends around
Principal Investigator
by Jonathan Hsu (ucsd)

Description

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.

Official Title

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

Keywords

Atrial Fibrillation (AF), ILR, AF, AFIB, Paroxysmal AF, Lone AF, Atrial Fibrillation

Eligibility

You can join if…

Open to people ages 18 years and up

  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.

You CAN'T join if...

  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.

Location

  • Sulpizio Cardiovascular Center accepting new patients
    La Jolla California 92037 United States

Lead Scientist at University of California Health

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT07434674
Study Type
Observational
Participants
Expecting 100 study participants
Last Updated