Using an implantable cardiac monitor to detect atrial fibrillation in heart failure patients
Official title: Insertable Cardiac Monitor for Primary Atrial Fibrillation Detection in High-Risk Heart Failure Patients (ASSERT-AF)
Run by University of Rochester · NCT04818645 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing whether an implantable heart monitor can help find undiagnosed atrial fibrillation in people with heart failure to improve their health and reduce the risk of serious complications.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 477 (estimated) |
| Sponsor | University of Rochester Academic / other |
| Locations | 1 site (Rochester, New York) |
| Trial ID | NCT04818645 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults over 18 years old with heart failure who have experienced recent exacerbations and are at risk for cardiac arrhythmias.
✕Probably not a fit
Patients who already have an implantable cardioverter defibrillator, biventricular ICD, implantable cardiac monitor, or pacemaker will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study focuses on patients with heart failure who are at high risk for undiagnosed atrial fibrillation, a condition that can lead to serious complications such as stroke. It involves the insertion of an implantable cardiac monitor (ICM) that provides long-term monitoring of heart rhythms remotely. The goal is to accurately assess the prevalence of atrial fibrillation and other arrhythmias in this population, which is often overlooked by conventional monitoring methods. By identifying these conditions early, the study aims to improve patient outcomes and reduce the risk of stroke and mortality associated with atrial fibrillation.
Why it matters
Potential benefit: If successful, this approach could lead to earlier detection of atrial fibrillation in heart failure patients, potentially reducing the risk of stroke and improving overall survival rates.
How similar studies have gone: Other studies have shown promise in using implantable cardiac monitors for detecting atrial fibrillation, indicating that this approach is supported by previous research.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male and female patients more than 18 years of age (no upper age limit) * HF exacerbation requiring initiation or augmentation of decongestive therapy in a hospital setting (hospitalization or emergency department visit) during the past 24 calendar months prior to consent date OR current treatment with loop-diuretics (furosemide, bumetanide, or torsemide). * LVEF \> 35% on a cardiac imaging study (echocardiogram, nuclear imaging, cardiac magnetic resonance imaging) performed during the past 24 calendar months prior to consent date * One or more FDA-approved indications for an Abbott ICM (unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias). * Willing to undergo an Abbott ICM implant and agree to remote ICM monitoring. Exclusion Criteria: * Existing implantable cardioverter defibrillator (ICD), biventricular ICD, implantable cardiac monitor or pacemaker. * Known or documented history AF or atrial flutter any time in past. * Has had a heart transplant * Participation in other clinical trials (observational registries are allowed with approval from the Coordination Center) * Unable or unwilling to cooperate with the protocol * Unable or unwilling to sign the consent for participation
Where it's running
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University of Rochester Medical Center
Rochester, New York, United States Recruiting
Study contacts
- Principal investigator: Ilan Goldenberg, MD — University of Rochester
- Study coordinator: Ilan Goldenberg, MD
- Email: ilan.goldenberg@heart.rochester.edu
- Phone: 585-275-5391
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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A village doctor–led telemedicine program will try to improve heart failure management in rural AF patients aged 65–80 compared with usual care.
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Village doctor–led telehealth care to prevent heart failure in AF patients
A village doctor–led telehealth program tests whether integrated, guideline-based care can help older adults with atrial fibrillation in rural China stay healthier and avoid heart failure compared with usual care.
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RHYthm and Myocardial Function Relationship in Heart Disease
This study tests how heart rhythm patterns relate to heart muscle function in adults with arrhythmias or cardiomyopathy.
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Longitudinal Assessment of Cardiac MRI Microstructure in Patients and Healthy People
This study tests advanced, non-contrast and extended clinical cardiac MRI techniques to see how heart tissue features differ between people with heart disease and healthy individuals.
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Using BIOMONITOR IV to track heart rhythm and warning signs in people with heart failure
This project will test whether a small implanted monitor called BIOMONITOR IV can track irregular heartbeats and body signals in people with heart failure who do not have ICD/CRT devices to see if it can warn doctors before the heart failure gets worse.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.