NCT04830774

Natural History of COVID-19-Related Atrial Fibrillation

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Texas Cardiac Arrhythmia Research Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COVID-19
• Atrial Fibrillation New Onset

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-04-15
• Primary completion: 2021-12-31
• Completion: 2023-12-31
• First posted: 2021-04-05
• Last updated: 2021-11-23

Locations

12 sites across 3 countries: United States, Belgium, Italy