Status:
RECRUITING
Insertable Cardiac Monitor for Primary Atrial Fibrillation Detection in High-Risk Heart Failure Patients
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
Abbott
Conditions:
Atrial Fibrillation
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 m...
Detailed Description
Over 6 million people in the United States suffer from heart failure (HF). By the year 2030 the prevalence of HF is expected to exceed 8 million people. Heart failure accounts for 1 million hospital a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
477 Patients enrolled
Trial Details
Trial ID
NCT04818645
Start Date
January 31 2023
End Date
July 1 2028
Last Update
March 12 2025
Active Locations (1)
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1
University of Rochester Medical Center
Rochester, New York, United States, 14642