Natural History of COVID-19-Related Atrial Fibrillation

Purpose

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.

Conditions

  • COVID-19
  • Atrial Fibrillation New Onset

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts 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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Single Group Assignment
Primary Purpose
Screening
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
COVID-19 patients with new-onset AF 		Consecutive patients with a confirmed diagnosis of COVID-19 with a first clinical episode of AF at admission or during hospitalization.
  • Device: ILR, 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

Recruiting Locations

More Details

NCT ID
NCT04830774
Status
Unknown status
Sponsor
Texas Cardiac Arrhythmia Research Foundation

Study Contact

Domenico G Della Rocca, MD
(512) 807-3150
domenicodellarocca@hotmail.it

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.