An interventional study of ILR, PMK, ICD in COVID-19 and Atrial Fibrillation New Onset, sponsored by Texas Cardiac Arrhythmia Research Foundation. Status unknown at 12 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-23.
Sponsored by Texas Cardiac Arrhythmia Research Foundation · Not applicable, Interventional, and Screening
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.
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.
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's planned enrollment of 200 is above the median of 102 across 4,364 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Texas Cardiac Arrhythmia Research Foundation is the lead sponsor of 36 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Patients with:
Exclusion Criteria:
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
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.
Time frame: 3 years
AF Progression
Time frame: 3 years
Time to adjudicated ischemic stroke/transient ischemic attack (TIA)/systemic arterial embolism
Time frame: 3 years
Composite of all-cause mortality, stroke and bleeding
Time frame: 3 years
Time to adjudicated cardiovascular death
Time frame: 3 years
Plan to share: No
This study is status unknown, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Texas Cardiac Arrhythmia Research Foundation