Atrial Fibrillation New Onset, COVID-19
Conditions
Keywords
atrial fibrillation, COVID-19, natural history, stroke, loop recorder, cardiac implantable electronic device, remote monitoring
Brief summary
The unCOVer-AF prospective, multicenter registry aims at determining the natural history of atrial fibrillation (AF) via continuous cardiac rhythm monitoring in patients with a first arrhythmic episode during COVID-19 hospitalization.
Detailed description
Coronavirus Disease 2019 (COVID-19) is a novel coronavirus strain disease, which has rapidly spread worldwide with more than 100 million confirmed cases to date. COVID-19 is mainly characterized by respiratory symptoms; however, patients can exhibit a wide range of clinical manifestations, including cardiovascular complications. Among them, supraventricular and ventricular arrhythmias have been described in patients at different stages of disease severity. According to a recent study on 9564 COVID-19 patients, 17.6% developed AF during hospitalization, 65.7% of whom without a past arrhythmic history. Several factors (e.g., hypoxia, systemic inflammatory response, myocardial injury) may interact with a preexisting substrate and act as a trigger for AF initiation. Nonetheless, the pathophysiology of COVID-19-related new-onset AF remains elusive. It is unknown whether the disease merely acts as a transient arrhythmia initiator or promotes long-term atrial electrophysiological and structural changes which may facilitate AF recurrence and progression. Therefore, the investigators designed a multicenter, prospective registry to assess the natural history of AF via continuous cardiac rhythm monitoring (ILR, PMK, ICD) in patients with a first AF episode during COVID-19 hospitalization.
Interventions
DEVICEILR, PMK, ICD
* Patients receive a newly implanted ILR, PMK, or ICD during COVID-19 hospitalization or within 30 days after hospital discharge and are followed by daily automated remote transmissions. * Patients have a previously implanted ILR, PMK, or ICD and are followed by daily automated remote transmissions
Sponsors
Texas Cardiac Arrhythmia Research Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Intervention model description
Single Group Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age\> 18 years; * Confirmed infection with SARS-CoV-2; * Patients with a first clinical episode of AF ≥30 s at admission or during hospitalization for COVID-19; * Patients with: 1. implantation of an ILR, a PMK, or an ICD during COVID-19 hospitalization or within 30 days after hospital discharge, or 2. an ILR, a PMK, or an ICD implanted before COVID-19 hospitalization.
Exclusion criteria
* History of AF or flutter irrespective of type; * Moderate/severe mitral stenosis; * Mechanical prosthetic heart valve(s); * Kidney failure treated with permanent dialysis; * Any condition (e.g. psychiatric illness, dementia) or situation, that in the investigators opinion could put the subject at significant risk, confound the study results, or interfere significantly with the subject participation in the study; * Unwillingness to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AF Burden | 3 years | AF burden is defined as cumulative duration of all AF episodes lasting ≥30 s from the first adjudicated AF episode onward, divided by total duration of monitoring. |
| AF Progression | 3 years | — |
| Time to adjudicated ischemic stroke/transient ischemic attack (TIA)/systemic arterial embolism | 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Composite of all-cause mortality, stroke and bleeding | 3 years |
| Time to adjudicated cardiovascular death | 3 years |
Countries
Belgium, Italy, United States
Contacts
Primary ContactDomenico G Della Rocca, MD
Backup ContactMichele Magnocavallo, MD
Outcome results
None listed