Natural History of COVID-19-Related Atrial Fibrillation

NCT04830774 | Unknown DMC

• 1 other identifier: TCAI-unCOVer1
• Study Type: interventional
• Target: 200
• Locations: 3 countries
• Sites: 12

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.

Conditions

COVID-19; Atrial Fibrillation New Onset

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (2)

• Composite of all-cause mortality, stroke and bleeding

  3 years

• Time to adjudicated cardiovascular death

  3 years

Study Arms (1)

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.

Device: ILR, PMK, ICD

Interventions

ILR, PMK, ICD 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

COVID-19 patients with new-onset AF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Texas Cardiac Arrhythmia Research Foundation: lead

Study Sites (12)

Kansas City Heart Rhythm Institute, Overland Park

Kansas City, Kansas, 66211, United States

NOT YET RECRUITING

Texas Cardiac Arrhythmia Institute

Austin, Texas, 78723, United States

NOT YET RECRUITING

Vrije Universiteit Brussel

Brussels, Belgium

NOT YET RECRUITING

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

Rome, Lazio, Italy

RECRUITING

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

Milan, Lombardy, Italy

RECRUITING

Ospedale San Donato

Arezzo, Italy

NOT YET RECRUITING

Maria Cecilia Hospital

Cotignola, Italy

NOT YET RECRUITING

Universita' Vanvitelli

Napoli, Italy

NOT YET RECRUITING

ARNAS Ospedale Civico

Palermo, Italy

NOT YET RECRUITING

Università di Pisa

Pisa, Italy

RECRUITING

Policlinico Gemelli

Roma, Italy

NOT YET RECRUITING

Ospedale San Bortolo

Vicenza, Italy

NOT YET RECRUITING

Related Publications (1)

• 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.

  PMID: 33493650 BACKGROUND

MeSH Terms

Conditions

COVID-19; Atrial Fibrillation; Stroke

Interventions

Defibrillators, Implantable

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Defibrillators; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Electrodes, Implanted; Prostheses and Implants

Study Officials

• Domenico G Della Rocca, MD

  Texas Cardiac Arrhythmia Research Foundation

  STUDY DIRECTOR

• Andrea Natale, MD

  Texas Cardiac Arrhythmia Research Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Domenico G Della Rocca, MD

CONTACT

(512) 807-3150; domenicodellarocca@hotmail.it

Michele Magnocavallo, MD

CONTACT

michelefg91@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Medical Director

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: April 1, 2021
• First Posted: April 5, 2021
• Study Start: April 15, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2023
• Last Updated: November 23, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); US (2); IT (9)