Natural History of COVID-19-Related Atrial Fibrillation

COVID-19 Clinical Trial

— unCOVer-AF  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04830774
• Other study ID #: TCAI-unCOVer1
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2021
• Source: Texas Cardiac Arrhythmia Research Foundation
• Contact: Domenico G Della Rocca, MD
• Phone: (512) 807-3150
• Email: domenicodellarocca[@]hotmail.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation New Onset
• COVID-19

Intervention

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

Locations

Country	Name	City	State
Belgium	Vrije Universiteit Brussel	Brussel
Italy	Ospedale San Donato	Arezzo
Italy	Maria Cecilia Hospital	Cotignola
Italy	Cardiology Unit, ASST-Fatebenefratelli Sacco, Luigi Sacco University Hospital, Milan, Italy	Milan	Lombardia
Italy	Universita' Vanvitelli	Napoli
Italy	ARNAS Ospedale Civico	Palermo
Italy	Università di Pisa	Pisa
Italy	Policlinico Gemelli	Roma
Italy	Department of Cardiovascular/Respiratory Diseases, Nephrology, Anesthesiology, and Geriatric Sciences, Policlinico Umberto I, Sapienza University of Rome	Rome	Lazio
Italy	Ospedale San Bortolo	Vicenza
United States	Texas Cardiac Arrhythmia Institute	Austin	Texas
United States	Kansas City Heart Rhythm Institute, Overland Park	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Cardiac Arrhythmia Research Foundation

Countries where clinical trial is conducted

United States,  Belgium,  Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AF 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.	3 years
Primary	AF Progression		3 years
Primary	Time to adjudicated ischemic stroke/transient ischemic attack (TIA)/systemic arterial embolism		3 years
Secondary	Composite of all-cause mortality, stroke and bleeding		3 years
Secondary	Time to adjudicated cardiovascular death		3 years