||Confirm Rx Insertable Cardiac Monitor for Primary Atrial Fibrillation Detection in High-Risk Heart Failure Patients
Atrial Fibrillation, Heart Failure
||Guy Rozen, MD
The main objective of this study is to compare the time of first detection of atrial fibrillation lasting > 5 minutes using an Abbott insertable cardiac monitor (ICM) compared to non-ICM monitoring in symptomatic heart failure patients.
1) HF exacerbation requiring initiation or augmentation of decongestive therapy in a hospital setting during the past 12 calendar months prior to the consent date 2) LVEF > 35% on a cardiac imaging study (echocardiogram, nuclear imaging, cardiac magnetic resonance imaging) perfmed during the past 12 calendar months prior to the consent date 3) One or more FDA-approved indications for an Abbott insertable cardiac monitor (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)
1) Existing implantable cardioverter defibrillator or pacemaker 2) Known or documented history atrial fibrillation or atrial flutter any time in the past 3) Participation in other clinical trials (observational registries are allowed with approval from the DCC)
Subject participation may last up to about 24 months. When enrolled in the study, participants will be randomized to one of two groups, the implantable cardiac monitor (ICM) group and a non-ICM group. All participants will have standard of care 12-lead ECGs at the baseline of their participation, 6, 12, 18, and 24 month visits. Creatinine and BUN will be tested at baseline, 6, 12, 18, and 24 month visits. There will be chart reviews for both groups to include information about clinical status, cardiovascular medications, and general medical record review. For the ICM group, there will be an ICM implantation procedure and interrogation data from the ICM and ICM status. There will be an app that communicates with your ICM that is downloaded onto your smartphone, allowing for the transmission of data from your ICM device to your provider through the Merlin.net Patient Care Network. For the Non-ICM group, there will not be any additional study activities.