RecruitingNot ApplicableNCT04818645

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)

Sponsor

University of Rochester

Enrollment

477 participants

Start Date

Jan 31, 2023

Study Type

INTERVENTIONAL

Conditions

Heart Failure Atrial Fibrillation

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria6

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

Interventions

DEVICEASSERT Insertable Cardiac Monitor

Subjects will be subcutaneously implanted with an Abbott ASSERT ICM with the device implant procedure per standard of care and current labelling. Data related to subjects' arrhythmias, via the Merlin.net Patient CareNetwork will be transmitted on a monthly basis to the treating physician and subsequently to the study coordination and database center (CCRC) at the University of Rochester. Data on the frequency/types of symptomatic (patient triggered) versus ICM detected (asymptomatic) arrhythmic events will be collected and adjudicated. Clinical data on medication, device interventions, cardiovascular events will be collected at follow-up visits.

OTHERConventional Management and monitoring

Subjects randomized to the conventional management arm of the trial will undergo arrhythmia monitoring based on clinical indications and per standard available modalities including periodic electrocardiograms (ECG), Holter and/or event monitoring.