COVID-19unCOVer-AFNCT04830774
Natural History of COVID-19-Related Atrial Fibrillation
A study testing ILR, PMK, ICD in people with COVID-19 and Atrial Fibrillation New Onset, run by Texas Cardiac Arrhythmia Research Foundation at 12 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Atrial Fibrillation New Onset
- What is being tested?
- ILR, PMK, ICD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 12 sitesin 3 countries
- Study dates
- 15 Apr 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
12 sites in 3 countries.
Michele Magnocavallo, MD contact
12 sites in 3 countries
Italy9 sites, 9 recruiting
- Not yet recruiting
Ospedale San Donato
Arezzo
Pasquale Notarstefano, MD
- Not yet recruiting
Maria Cecilia Hospital
Cotignola
Saverio Iacopino, MD
- Recruiting
Cardiology Unit, ASST-Fatebenefratelli Sacco, Luigi Sacco University Hospital, Milan, Italy
Milan, Lombardy
Giovanni B Forleo, MD
Marco Schiavone, MD
- Not yet recruiting
Universita' Vanvitelli
Naples
Vincenzo Russo, MD
- Not yet recruiting
ARNAS Ospedale Civico
Palermo
Giuseppe Sgarito, MD
- Recruiting
Università di Pisa
Pisa
Luca Segreti, MD
- Not yet recruiting
Policlinico Gemelli
Roma
Francesco Perna, MD
- Recruiting
Department of Cardiovascular/Respiratory Diseases, Nephrology, Anesthesiology, and Geriatric Sciences, Policlinico Umberto I, Sapienza University of Rome
Rome, Lazio
Carlo Lavalle, MD
Michele Magnocavallo, MD
- Not yet recruiting
Ospedale San Bortolo
Vicenza
Antonio Rossillo, MD
United States2 sites, 2 recruiting
- Not yet recruiting
Texas Cardiac Arrhythmia Institute
Austin, Texas, 78723
Domenico G Della Rocca, MD
- Not yet recruiting
Kansas City Heart Rhythm Institute, Overland Park
Kansas City, Kansas, 66211
Dhanunjaya Lakkireddy, MD
Belgium1 site, 1 recruiting
- Not yet recruiting
Vrije Universiteit Brussel
Brussels
Carlo De Asmundis, MD
Cinzia Monaco, MD
About this study
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
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.
Read the 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.
- Conditions
- COVID-19, Atrial Fibrillation New Onset
- Being tested
- ILR, PMK, ICD
- Keywords
- atrial fibrillation, COVID-19, natural history, stroke, loop recorder, cardiac implantable electronic device, remote monitoring
- Medical subject headings
- COVID-19, Atrial Fibrillation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ILR, PMK, ICDDevice
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: ILR, PMK, ICD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
AF Progression
Measured: 3 years
Time to adjudicated ischemic stroke/transient ischemic attack (TIA)/systemic arterial embolism
Measured: 3 years
Secondary outcomes (2)
Composite of all-cause mortality, stroke and bleeding
Measured: 3 years
Time to adjudicated cardiovascular death
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start15 Apr 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas Cardiac Arrhythmia Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Natale, Texas Cardiac Arrhythmia Research Foundation
- Investigators
- Domenico G Della Rocca, MD, Study director, Texas Cardiac Arrhythmia Research FoundationAndrea Natale, MD, Principal investigator, Texas Cardiac Arrhythmia Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04830774
- Sponsor's protocol ID
- TCAI-unCOVer1
- Acronym
- unCOVer-AF
- Status last verified
- Nov 2021
- First submitted
- 1 Apr 2021
- Last updated
- 23 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33493650
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04830774
- Acronym / sponsor ID
- unCOVer-AF / TCAI-unCOVer1
- Conditions
- COVID-19, Atrial Fibrillation New Onset
- Keywords
- atrial fibrillation, COVID-19, natural history, stroke, loop recorder, cardiac implantable electronic device, remote monitoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Texas Cardiac Arrhythmia Research FoundationUniversity, hospital or other
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 5 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| COVID-19 patients with new-onset AF | Other | Device: ILR, PMK, ICDConsecutive patients with a confirmed diagnosis of COVID-19 with a first clinical episode of AF at admission or during hospitalization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | COVID-19 patients with new-onset AF |
Primary outcome
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.
AF Progression
Time frame: 3 years
Time to adjudicated ischemic stroke/transient ischemic attack (TIA)/systemic arterial embolism
Time frame: 3 years
2 secondary outcomes
Composite of all-cause mortality, stroke and bleeding
Time frame: 3 years
Time to adjudicated cardiovascular death
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
- Background: PubMed 33493650Mountantonakis 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele Magnocavallo, MD contact
Domenico G Della Rocca, MD study director
Texas Cardiac Arrhythmia Research Foundation
Andrea Natale, MD principal investigator
Texas Cardiac Arrhythmia Research Foundation
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ILR, PMK, ICD in people with COVID-19 and Atrial Fibrillation New Onset, run by Texas Cardiac Arrhythmia Research Foundation at 12 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Italy, United States, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Domenico G Della Rocca, MD ((512) 807-3150, domenicodellarocca@hotmail.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AF Burden (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04830774, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2021.