NCT04818645Active, not recruiting
Insertable Cardiac Monitor for Primary Atrial Fibrillation Detection in High-Risk Heart Failure Patients
Insertable Cardiac Monitor for Primary Atrial Fibrillation Detection in High-Risk Heart Failure Patients (ASSERT-AF)
Source: ClinicalTrials.gov · Last updated 23 Mar 2026
Brief summary (registry, in English)
Patients with heart failure (HF) represent a large population of patients who are at high risk for complications related to undiagnosed atrial fibrillation (AF). However, currently there are limited modalities for early AF detection and subsequent stroke prevention in this high-risk population. An implantable cardiac monitor (ICM) is inserted subcutaneously and can provide long term arrhythmia information via remote monitoring. The ASSERT-AF study seeks to accurately define the burden of AF and other arrhythmias in high-risk HF patients using an ASSERT ICM.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 477 (estimated)
- First submitted
- 24 Mar 2021
- Start date
- 31 Jan 2023
- Primary completion date
- 1 Jul 2028
- Lead sponsor
- University of Rochester
- Diseases
- Heart failure, Stroke, Atrial fibrillation
- NCT number
- NCT04818645
What you commit to
- Study type: Interventional
- Planned participants: 477
- From 31 Jan 2023 to the primary completion date, 1 Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Existing implantable cardioverter defibrillator (ICD), biventricular ICD, implantable cardiac monitor or pacemaker.
- Has had a heart transplant
Other
- Known or documented history AF or atrial flutter any time in past.
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Rochester Medical Center Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.