Atrial Fibrillation (AF)ILR-AFNCT07434674
Incidence of Long-TeRm Atrial Fibrillation After Acute Illness
An observational study of Atrial Fibrillation (AF), run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF)
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2025to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Sulpizio Cardiovascular Center
La Jolla, California, 92037
About this study
Official title: Incidence of Long-TeRm Atrial Fibrillation After Acute Illness (ILR-AF)
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
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ILR | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months
Secondary outcomes (10)
Time to first documented AF by 6 months
Measured: 6 months
Time to first documented AF episode lasting ≥ 5 minutes
Measured: 12 months
Mean AF burden
Measured: 12 months
Mean AF episode length
Measured: 12 months
Change in use of oral anticoagulation and antiarrhythmic drugs
Measured: 12 months
Quality of life scores (SF-36)
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).
Measured: 12 months
Incidence of hospitalization
Measured: 12 months
Change in medication use
Measured: 12 months
Incidence of stroke
Measured: 12 months
Incidence of death
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start1 Nov 2025
- Primary completionNov 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Principal investigator, Jonathan Hsu, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07434674
- Sponsor's protocol ID
- 812338
- Acronym
- ILR-AF
- Status last verified
- Feb 2026
- First submitted
- 21 Dec 2025
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In general, de-identified data may be shared with other researchers for scientific purposes, subject to IRB approval and any data sharing agreements. Any such sharing will not include information that could reasonably identify individual participants. No plans to publish participant family pedigrees are anticipated for this study.
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Long-TeRm Atrial Fibrillation After Acute Illness (ILR-AF)
- ClinicalTrials.gov ID
- NCT07434674
- Acronym / sponsor ID
- ILR-AF / 812338
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- ILR, AF, AFIB, Paroxysmal AF, Lone AF
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ILR | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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:
- Patient or legally authorized representative signs and dates the patient consent form.
- Patient is ≥18 years old.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
10 secondary outcomes
Time to first documented AF by 6 months
Time frame: 6 months
Time to first documented AF episode lasting ≥ 5 minutes
Time frame: 12 months
Mean AF burden
Time frame: 12 months
Mean AF episode length
Time frame: 12 months
Change in use of oral anticoagulation and antiarrhythmic drugs
Time frame: 12 months
Quality of life scores (SF-36)
Time frame: 12 months
Incidence of hospitalization
Time frame: 12 months
Change in medication use
Time frame: 12 months
Incidence of stroke
Time frame: 12 months
Incidence of death
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: Yes. In general, de-identified data may be shared with other researchers for scientific purposes, subject to IRB approval and any data sharing agreements. Any such sharing will not include information that could reasonably identify individual participants. No plans to publish participant family pedigrees are anticipated for this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation (AF), run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin U Hoffman, MD, PhD (858-246-2016, b2hoffman@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first documented event of AF by 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.