Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COVID-19 patients with new-onset AF | Other | Consecutive patients with a confirmed diagnosis of COVID-19 with a first clinical episode of AF at admission or during hospitalization. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ILR, PMK, ICD | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| AF Progression | 3 years | |
| Time to adjudicated ischemic stroke/transient ischemic attack (TIA)/systemic arterial embolism | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of all-cause mortality, stroke and bleeding | 3 years | |
| Time to adjudicated cardiovascular death | 3 years |
Not provided
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:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Domenico G Della Rocca, MD | Contact | (512) 807-3150 | domenicodellarocca@hotmail.it | |
| Michele Magnocavallo, MD | Contact | michelefg91@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Domenico G Della Rocca, MD | Texas Cardiac Arrhythmia Research Foundation | Study Director |
| Andrea Natale, MD | Texas Cardiac Arrhythmia Research Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kansas City Heart Rhythm Institute, Overland Park | Not yet recruiting | Kansas City | Kansas | 66211 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33493650 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D001281 | Atrial Fibrillation |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D017147 | Defibrillators, Implantable |
| ID | Term |
|---|---|
| D047548 | Defibrillators |
| D004566 | Electrodes |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
Not provided
Not provided
Single Group Assignment
Not provided
Not provided
Not provided
Not provided
|
| Texas Cardiac Arrhythmia Institute | Not yet recruiting | Austin | Texas | 78723 | United States |
|
| Vrije Universiteit Brussel | Not yet recruiting | Brussels | Belgium |
|
| Department of Cardiovascular/Respiratory Diseases, Nephrology, Anesthesiology, and Geriatric Sciences, Policlinico Umberto I, Sapienza University of Rome | Recruiting | Rome | Lazio | Italy |
|
| Cardiology Unit, ASST-Fatebenefratelli Sacco, Luigi Sacco University Hospital, Milan, Italy | Recruiting | Milan | Lombardy | Italy |
|
| Ospedale San Donato | Not yet recruiting | Arezzo | Italy |
|
| Maria Cecilia Hospital | Not yet recruiting | Cotignola | Italy |
|
| Universita' Vanvitelli | Not yet recruiting | Naples | Italy |
|
| ARNAS Ospedale Civico | Not yet recruiting | Palermo | Italy |
|
| Università di Pisa | Recruiting | Pisa | Italy |
|
| Policlinico Gemelli | Not yet recruiting | Roma | Italy |
|
| Ospedale San Bortolo | Not yet recruiting | Vicenza | Italy |
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D004567 |
| Electrodes, Implanted |
| D019736 | Prostheses and Implants |