Natural History of COVID-19-Related Atrial Fibrillation (unCOVer-AF)

November 15, 2021 updated by: Andrea Natale, Texas Cardiac Arrhythmia Research Foundation

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Brussel, Belgium
        • Not yet recruiting
        • Vrije Universiteit Brussel
        • Contact:
          • Carlo De Asmundis, MD
        • Contact:
          • Cinzia Monaco, MD
  • Italy
      • Arezzo, Italy
        • Not yet recruiting
        • Ospedale San Donato
        • Contact:
          • Pasquale Notarstefano, MD
      • Cotignola, Italy
        • Not yet recruiting
        • Maria Cecilia Hospital
        • Contact:
          • Saverio Iacopino, MD
      • Napoli, Italy
        • Not yet recruiting
        • Universita' Vanvitelli
        • Contact:
          • Vincenzo Russo, MD
      • Palermo, Italy
        • Not yet recruiting
        • ARNAS Ospedale Civico
        • Contact:
          • Giuseppe Sgarito, MD
      • Pisa, Italy
        • Recruiting
        • Università di Pisa
        • Contact:
          • Luca Segreti, MD
      • Roma, Italy
        • Not yet recruiting
        • Policlinico Gemelli
        • Contact:
          • Francesco Perna, MD
      • Vicenza, Italy
        • Not yet recruiting
        • Ospedale San Bortolo
        • Contact:
          • Antonio Rossillo, MD
    • Lazio
      • Rome, Lazio, Italy
        • Recruiting
        • Department of Cardiovascular/Respiratory Diseases, Nephrology, Anesthesiology, and Geriatric Sciences, Policlinico Umberto I, Sapienza University of Rome
        • Contact:
          • Carlo Lavalle, MD
        • Contact:
          • Michele Magnocavallo, MD
    • Lombardia
      • Milan, Lombardia, Italy
        • Recruiting
        • Cardiology Unit, ASST-Fatebenefratelli Sacco, Luigi Sacco University Hospital, Milan, Italy
        • Contact:
          • Giovanni B Forleo, MD
        • Contact:
          • Marco Schiavone, MD
  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66211
        • Not yet recruiting
        • Kansas City Heart Rhythm Institute, Overland Park
        • Contact:
          • Dhanunjaya Lakkireddy, MD
    • Texas
      • Austin, Texas, United States, 78723
        • Not yet recruiting
        • Texas Cardiac Arrhythmia Institute
        • Contact:
          • Domenico G Della Rocca, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AF Burden
Time Frame: 3 years
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
Time Frame: 3 years
3 years
Time to adjudicated ischemic stroke/transient ischemic attack (TIA)/systemic arterial embolism
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Composite of all-cause mortality, stroke and bleeding
Time Frame: 3 years
3 years
Time to adjudicated cardiovascular death
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Texas Cardiac Arrhythmia Research Foundation

Investigators

  • Study Director: Domenico G Della Rocca, MD, Texas Cardiac Arrhythmia Research Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2021

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

April 1, 2021

First Submitted That Met QC Criteria

April 1, 2021

First Posted (Actual)

April 5, 2021

Study Record Updates

Last Update Posted (Actual)

November 23, 2021

Last Update Submitted That Met QC Criteria

November 15, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCAI-unCOVer1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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