Clinical trial NCT04830774: Natural History of COVID-19-Related Atrial Fibrillation
Official title: Natural History and Recurrence Rate of Atrial Fibrillation After the First, COVID-19-Related Atrial Arrhythmic Episode: A Prospective Evaluation Using Continuous Cardiac Rhythm Monitoring
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Atrial Fibrillation New Onset
Keywords: atrial fibrillation
COVID-19
natural history
stroke
loop recorder
cardiac implantable electronic device
remote monitoring
Lead sponsor: Texas Cardiac Arrhythmia Research Foundation
Sponsor class: OTHER
First posted: 2021-04-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment
Primary purpose: SCREENING

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.

Eligibility criteria: 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.

Primary outcomes:
measure: AF Burden
timeFrame: 3 years
measure: AF Progression
timeFrame: 3 years
measure: Time to adjudicated ischemic stroke/transient ischemic attack (TIA)/systemic arterial embolism
timeFrame: 3 years
Secondary outcomes:
measure: Composite of all-cause mortality, stroke and bleeding
timeFrame: 3 years
measure: Time to adjudicated cardiovascular death
timeFrame: 3 years
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Kansas City Heart Rhythm Institute, Overland Park
state: Kansas
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Institute
state: Texas
city: Brussel
country: Belgium
facility: Vrije Universiteit Brussel
city: Rome
country: Italy
facility: Department of Cardiovascular/Respiratory Diseases, Nephrology, Anesthesiology, and Geriatric Sciences, Policlinico Umberto I, Sapienza University of Rome
state: Lazio
city: Milan
country: Italy
facility: Cardiology Unit, ASST-Fatebenefratelli Sacco, Luigi Sacco University Hospital, Milan, Italy
state: Lombardia
city: Arezzo
country: Italy
facility: Ospedale San Donato
city: Cotignola
country: Italy
facility: Maria Cecilia Hospital
city: Napoli
country: Italy
facility: Universita' Vanvitelli
city: Palermo
country: Italy
facility: ARNAS Ospedale Civico
city: Pisa
country: Italy
facility: Università di Pisa
city: Roma
country: Italy
facility: Policlinico Gemelli
city: Vicenza
country: Italy
facility: Ospedale San Bortolo
Study officials:
affiliation: Texas Cardiac Arrhythmia Research Foundation
name: Domenico G Della Rocca, MD
role: STUDY_DIRECTOR
affiliation: Texas Cardiac Arrhythmia Research Foundation
name: Andrea Natale, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mountantonakis SE, Saleh M, Fishbein J, Gandomi A, Lesser M, Chelico J, Gabriels J, Qiu M, Epstein LM; Northwell COVID-19 Research Consortium. Atrial fibrillation is an independent predictor for in-hospital mortality in patients admitted with SARS-CoV-2 infection. Heart Rhythm. 2021 Apr;18(4):501-507. doi: 10.1016/j.hrthm.2021.01.018. Epub 2021 Jan 22.