Incidence of Long-TeRm Atrial Fibrillation After Acute Illness

NCT07434674 | Recruiting

• 1 other identifier: 812338
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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)

Keywords

ILR; AF; AFIB; Paroxysmal AF; Lone AF

Outcome Measures

Primary Outcomes (1)

• Time to first documented event of AF by 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).

  12 months

Secondary Outcomes (10)

• Time to first documented AF by 6 months

  6 months

• Time to first documented AF episode lasting ≥ 5 minutes

  12 months

• Mean AF burden

  12 months

• Mean AF episode length

  12 months

• Change in use of oral anticoagulation and antiarrhythmic drugs

  12 months

Study Arms (1)

ILR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The selection of participants for this study will be equitable, and no specific populations will be excluded without a clear and compelling rationale related to the health of the participants or the purpose of the research. Limited English proficiency will not be an exclusion criterion.

You may qualify if:

• 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:
• lead ECG for AF detection
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Sulpizio Cardiovascular Center

La Jolla, California, 92037, United States

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Benjamin U Hoffman, MD, PhD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: December 21, 2025
• First Posted: February 25, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)