Who is eligible for clinical trial NCT04818645?

Participants must meet the protocol's inclusion criteria for Atrial Fibrillation. The stated age range is 18 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT04818645 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-03-19

Insertable Cardiac Monitor for Primary Atrial Fibrillation Detection in High-Risk Heart Failure Patients (NCT04818645)

Insertable Cardiac Monitor for Primary Atrial Fibrillation Detection in High-Risk Heart Failure Patients (ASSERT-AF)

🔵 Active, Not Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: University of Rochester

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (7 items).

Location: University of Rochester Medical Center — Rochester, New York

Age range: 18 Years

🧪 Interventions in This Study

ASSERT Insertable Cardiac Monitor (DEVICE)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

University of Rochester Medical Center — Rochester, New York

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Atrial Fibrillation

HeartBeam ECG Registry — Pittsburgh, Pennsylvania
Amiodarone for the Prevention of Atrial Fibrillation After Minimally Invasive Esophagectomy in Patients With Esophageal Cancer — Portland, Oregon
CHAMPION-AF Clinical Trial — Birmingham, Alabama
Reversal of Atrial Substrate to Prevent Atrial — Calgary, Alberta
Pharmacogenetic Study of Antiarrhythmic Drugs for Atrial Fibrillation — Chicago, Illinois

Explore by condition: All Atrial Fibrillation clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Review the official NIH record below to find the coordinating site.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗