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Natural History of COVID-19-Related Atrial Fibrillation

NCT ID: NCT04830774

Last Updated: 2021-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-15

Study Completion Date

2023-12-31

Brief Summary

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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

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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

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COVID-19 Atrial Fibrillation New Onset

Keywords

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atrial fibrillation COVID-19 natural history stroke loop recorder cardiac implantable electronic device remote monitoring

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single Group Assignment
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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COVID-19 patients with new-onset AF

Consecutive patients with a confirmed diagnosis of COVID-19 with a first clinical episode of AF at admission or during hospitalization.

Group Type OTHER

ILR, PMK, ICD

Intervention Type DEVICE

* 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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Texas Cardiac Arrhythmia Research Foundation

OTHER

Sponsor Role lead

Responsible Party

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Andrea Natale

Executive Medical Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Domenico G Della Rocca, MD

Role: STUDY_DIRECTOR

Texas Cardiac Arrhythmia Research Foundation

Andrea Natale, MD

Role: PRINCIPAL_INVESTIGATOR

Texas Cardiac Arrhythmia Research Foundation

Locations

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Kansas City Heart Rhythm Institute, Overland Park

Kansas City, Kansas, United States

Site Status NOT_YET_RECRUITING

Texas Cardiac Arrhythmia Institute

Austin, Texas, United States

Site Status NOT_YET_RECRUITING

Vrije Universiteit Brussel

Brussels, , Belgium

Site Status NOT_YET_RECRUITING

Department of Cardiovascular/Respiratory Diseases, Nephrology, Anesthesiology, and Geriatric Sciences, Policlinico Umberto I, Sapienza University of Rome

Rome, Lazio, Italy

Site Status RECRUITING

Cardiology Unit, ASST-Fatebenefratelli Sacco, Luigi Sacco University Hospital, Milan, Italy

Milan, Lombardy, Italy

Site Status RECRUITING

Ospedale San Donato

Arezzo, , Italy

Site Status NOT_YET_RECRUITING

Maria Cecilia Hospital

Cotignola, , Italy

Site Status NOT_YET_RECRUITING

Universita' Vanvitelli

Napoli, , Italy

Site Status NOT_YET_RECRUITING

ARNAS Ospedale Civico

Palermo, , Italy

Site Status NOT_YET_RECRUITING

Università di Pisa

Pisa, , Italy

Site Status RECRUITING

Policlinico Gemelli

Roma, , Italy

Site Status NOT_YET_RECRUITING

Ospedale San Bortolo

Vicenza, , Italy

Site Status NOT_YET_RECRUITING

Countries

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Switzerland Turkey (Türkiye) United States Belgium Italy

Central Contacts

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Domenico G Della Rocca, MD

Role: CONTACT

Phone: (512) 807-3150

Email: [email protected]

Michele Magnocavallo, MD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Dhanunjaya Lakkireddy, MD

Role: primary

Domenico G Della Rocca, MD

Role: primary

Carlo De Asmundis, MD

Role: primary

Cinzia Monaco, MD

Role: backup

Carlo Lavalle, MD

Role: primary

Michele Magnocavallo, MD

Role: backup

Giovanni B Forleo, MD

Role: primary

Marco Schiavone, MD

Role: backup

Pasquale Notarstefano, MD

Role: primary

Saverio Iacopino, MD

Role: primary

Vincenzo Russo, MD

Role: primary

Giuseppe Sgarito, MD

Role: primary

Luca Segreti, MD

Role: primary

Francesco Perna, MD

Role: primary

Antonio Rossillo, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 33493650 (View on PubMed)

Other Identifiers

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TCAI-unCOVer1

Identifier Type: -

Identifier Source: org_study_id