Long-term atrial fibrillation risk after an acute illness

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Sulpizio Cardiovascular Center
  La Jolla, California, United States Recruiting

Study contacts

• Study coordinator: Benjamin U Hoffman, MD, PhD
• Email: b2hoffman@health.ucsd.edu
• Phone: 858-246-2016

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.