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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
200
* 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
Kansas City Heart Rhythm Institute, Overland Park
Kansas City, Kansas, United States
NOT_YET_RECRUITINGTexas Cardiac Arrhythmia Institute
Austin, Texas, United States
NOT_YET_RECRUITINGAF Burden
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.
Time frame: 3 years
AF Progression
Time frame: 3 years
Time to adjudicated ischemic stroke/transient ischemic attack (TIA)/systemic arterial embolism
Time frame: 3 years
Composite of all-cause mortality, stroke and bleeding
Time frame: 3 years
Time to adjudicated cardiovascular death
Time frame: 3 years
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Vrije Universiteit Brussel
Brussels, Belgium
NOT_YET_RECRUITINGDepartment of Cardiovascular/Respiratory Diseases, Nephrology, Anesthesiology, and Geriatric Sciences, Policlinico Umberto I, Sapienza University of Rome
Rome, Lazio, Italy
RECRUITINGCardiology Unit, ASST-Fatebenefratelli Sacco, Luigi Sacco University Hospital, Milan, Italy
Milan, Lombardy, Italy
RECRUITINGOspedale San Donato
Arezzo, Italy
NOT_YET_RECRUITINGMaria Cecilia Hospital
Cotignola, Italy
NOT_YET_RECRUITINGUniversita' Vanvitelli
Napoli, Italy
NOT_YET_RECRUITINGARNAS Ospedale Civico
Palermo, Italy
NOT_YET_RECRUITINGUniversità di Pisa
Pisa, Italy
RECRUITING...and 2 more locations