Natural History of COVID-19-Related Atrial Fibrillation

Not Applicable

• Conditions: COVID-19; Atrial Fibrillation New Onset
• Interventions: Device: ILR, PMK, ICD

• Registration Number: NCT04830774
• Lead Sponsor: Texas Cardiac Arrhythmia Research Foundation

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.

Study Timeline

• Study First Submitted: 2021-04-01
• Study First Submitted QC: 2021-04-01
• Study First Posted: 2021-04-05
• Study Start: 2021-04-15
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-15
• Last Update Posted: 2021-11-23
• Primary Completion: 2021-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
COVID-19 patients with new-onset AF	ILR, PMK, ICD	Consecutive patients with a confirmed diagnosis of COVID-19 with a first clinical episode of AF at admission or during hospitalization.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Time to adjudicated cardiovascular death	3 years
Composite of all-cause mortality, stroke and bleeding	3 years

Trial Locations

Locations (12)

Vrije Universiteit Brussel; 🇧🇪 Brussel, Belgium

Texas Cardiac Arrhythmia Institute; 🇺🇸 Austin, Texas, United States

Cardiology Unit, ASST-Fatebenefratelli Sacco, Luigi Sacco University Hospital, Milan, Italy; 🇮🇹 Milan, Lombardia, Italy

Maria Cecilia Hospital; 🇮🇹 Cotignola, Italy

Ospedale San Donato; 🇮🇹 Arezzo, Italy

Universita' Vanvitelli; 🇮🇹 Napoli, Italy

Università di Pisa; 🇮🇹 Pisa, Italy

Policlinico Gemelli; 🇮🇹 Roma, Italy

Ospedale San Bortolo; 🇮🇹 Vicenza, Italy

Kansas City Heart Rhythm Institute, Overland Park; 🇺🇸 Kansas City, Kansas, United States

ARNAS Ospedale Civico; 🇮🇹 Palermo, Italy

Department of Cardiovascular/Respiratory Diseases, Nephrology, Anesthesiology, and Geriatric Sciences, Policlinico Umberto I, Sapienza University of Rome; 🇮🇹 Rome, Lazio, Italy