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

Primary Purpose

COVID-19, Atrial Fibrillation New Onset

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
ILR, PMK, ICD
Sponsored by
Texas Cardiac Arrhythmia Research Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for COVID-19 focused on measuring atrial fibrillation, COVID-19, natural history, stroke, loop recorder, cardiac implantable electronic device, remote monitoring

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kansas City Heart Rhythm Institute, Overland Park
  • Texas Cardiac Arrhythmia Institute
  • Vrije Universiteit Brussel
  • Department of Cardiovascular/Respiratory Diseases, Nephrology, Anesthesiology, and Geriatric Sciences, Policlinico Umberto I, Sapienza University of RomeRecruiting
  • Cardiology Unit, ASST-Fatebenefratelli Sacco, Luigi Sacco University Hospital, Milan, ItalyRecruiting
  • Ospedale San Donato
  • Maria Cecilia Hospital
  • Universita' Vanvitelli
  • ARNAS Ospedale Civico
  • Università di PisaRecruiting
  • Policlinico Gemelli
  • Ospedale San Bortolo

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

COVID-19 patients with new-onset AF

Arm Description

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

Outcomes

Primary Outcome Measures

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.
AF Progression
Time to adjudicated ischemic stroke/transient ischemic attack (TIA)/systemic arterial embolism

Secondary Outcome Measures

Composite of all-cause mortality, stroke and bleeding
Time to adjudicated cardiovascular death

Full Information

First Posted
April 1, 2021
Last Updated
November 15, 2021
Sponsor
Texas Cardiac Arrhythmia Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04830774
Brief Title
Natural History of COVID-19-Related Atrial Fibrillation
Acronym
unCOVer-AF
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Cardiac Arrhythmia Research Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Atrial Fibrillation New Onset
Keywords
atrial fibrillation, COVID-19, natural history, stroke, loop recorder, cardiac implantable electronic device, remote monitoring

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
COVID-19 patients with new-onset AF
Arm Type
Other
Arm Description
Consecutive patients with a confirmed diagnosis of COVID-19 with a first clinical episode of AF at admission or during hospitalization.
Intervention Type
Device
Intervention Name(s)
ILR, PMK, ICD
Intervention Description
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
Primary Outcome Measure Information:
Title
AF Burden
Description
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
Title
AF Progression
Time Frame
3 years
Title
Time to adjudicated ischemic stroke/transient ischemic attack (TIA)/systemic arterial embolism
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Composite of all-cause mortality, stroke and bleeding
Time Frame
3 years
Title
Time to adjudicated cardiovascular death
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: implantation of an ILR, a PMK, or an ICD during COVID-19 hospitalization or within 30 days after hospital discharge, or 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Domenico G Della Rocca, MD
Phone
(512) 807-3150
Email
domenicodellarocca@hotmail.it
First Name & Middle Initial & Last Name or Official Title & Degree
Michele Magnocavallo, MD
Email
michelefg91@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Domenico G Della Rocca, MD
Organizational Affiliation
Texas Cardiac Arrhythmia Research Foundation
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Andrea Natale, MD
Organizational Affiliation
Texas Cardiac Arrhythmia Research Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kansas City Heart Rhythm Institute, Overland Park
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dhanunjaya Lakkireddy, MD
Facility Name
Texas Cardiac Arrhythmia Institute
City
Austin
State/Province
Texas
ZIP/Postal Code
78723
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Domenico G Della Rocca, MD
Facility Name
Vrije Universiteit Brussel
City
Brussel
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlo De Asmundis, MD
First Name & Middle Initial & Last Name & Degree
Cinzia Monaco, MD
Facility Name
Department of Cardiovascular/Respiratory Diseases, Nephrology, Anesthesiology, and Geriatric Sciences, Policlinico Umberto I, Sapienza University of Rome
City
Rome
State/Province
Lazio
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlo Lavalle, MD
First Name & Middle Initial & Last Name & Degree
Michele Magnocavallo, MD
Facility Name
Cardiology Unit, ASST-Fatebenefratelli Sacco, Luigi Sacco University Hospital, Milan, Italy
City
Milan
State/Province
Lombardia
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giovanni B Forleo, MD
First Name & Middle Initial & Last Name & Degree
Marco Schiavone, MD
Facility Name
Ospedale San Donato
City
Arezzo
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pasquale Notarstefano, MD
Facility Name
Maria Cecilia Hospital
City
Cotignola
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saverio Iacopino, MD
Facility Name
Universita' Vanvitelli
City
Napoli
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincenzo Russo, MD
Facility Name
ARNAS Ospedale Civico
City
Palermo
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Sgarito, MD
Facility Name
Università di Pisa
City
Pisa
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luca Segreti, MD
Facility Name
Policlinico Gemelli
City
Roma
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesco Perna, MD
Facility Name
Ospedale San Bortolo
City
Vicenza
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Rossillo, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33493650
Citation
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.
Results Reference
background

Learn more about this trial

Natural History of COVID-19-Related Atrial Fibrillation

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