Using an implantable cardiac monitor to detect atrial fibrillation in heart failure patients
Insertable Cardiac Monitor for Primary Atrial Fibrillation Detection in High-Risk Heart Failure Patients (ASSERT-AF)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 477 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Rochester Academic / other |
| Locations | 1 site (Rochester, New York) |
| Trial ID | NCT04818645 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who already have an implantable cardioverter defibrillator, biventricular ICD, implantable cardiac monitor, or pacemaker will not benefit from this study.
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 performed: Other studies have shown promise in using implantable cardiac monitors for detecting atrial fibrillation, indicating that this approach is supported by previous research.
Eligibility criteria
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 this trial is running
Rochester, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.