Confirm Rx insertable cardiac monitor for primary atrial fibrillation detection in high-risk heart failure patients (Confirm-AF trial)

Mehmet K. Aktas*, Wojciech Zareba, Javed Butler, Arwa Younis, Scott McNitt, Mary W. Brown, Nikhila Rao, Nilesh Rao, Jonathan Steinberg, Leway Chen, Jeffrey D Alexis, Himabindu Vidula, Ilan Goldenberg

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

4 Scopus citations

Abstract

Background: 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 available for early AF detection in this high-risk population. An implantable cardiac monitor (ICM) is inserted subcutaneously and can provide long-term arrhythmia information via remote monitoring. Methods and Results: Confirm-AF is a prospective randomized, nonblinded, two arm, multicenter clinical trial to be performed in the United States, enrolling 477 patients with a history of HF hospitalization and left ventricular ejection fraction >35% from 30 medical sites. Patients will be randomized in a 2:1 fashion to undergo ICM implant with remote monitoring and symptom-triggered mobile app transmissions versus (vs.) Non-ICM management and follow-up. The primary objective of this trial is to compare the time to first detection of AF lasting > 5 min using an Abbott ICM compared to non-ICM monitoring in symptomatic HF patients. This article describes the design and analytic plan for the Confirm-AF trial. Conclusions: The Confirm-AF trial seeks to accurately define the burden of AF in high-risk HF patients with LVEF > 35% using an Abbott ICM. A finding showing significantly higher incidence of AF along with improved clinical outcomes with ICM monitoring is expected to have substantial clinical implications and may change the method of monitoring high-risk HF patients.

Original languageEnglish
Article numbere13021
JournalAnnals of Noninvasive Electrocardiology
Volume28
Issue number1
DOIs
StatePublished - Jan 2023
Externally publishedYes

Funding

FundersFunder number
Abbott Laboratories
Medical Center, University of Rochester

    Keywords

    • atrial fibrillation
    • heart failure
    • implantable cardiac monitor
    • remote monitoring
    • stroke

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