Natural History of COVID-19-Related Atrial Fibrillation (unCOVer-AF)

Texas Cardiac Arrhythmia Research Foundation

Status

Unknown

Conditions

COVID-19

Atrial Fibrillation New Onset

Treatments

Device: ILR, PMK, ICD

Study type

Interventional

Funder types

Other

Identifiers

NCT04830774

TCAI-unCOVer1

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.