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Device
Monitoring Atrial Fibrillation After COVID-19 (unCOVer-AF Trial)
N/A
Waitlist Available
Led By Andrea Natale, MD
Research Sponsored by Texas Cardiac Arrhythmia Research Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
unCOVer-AF Trial Summary
This trial is looking at the natural history of atrial fibrillation (AF) in patients who have had their first arrhythmic episode during COVID-19 hospitalization.
Who is the study for?
This trial is for adults over 18 who had their first episode of atrial fibrillation during COVID-19 hospitalization. They must have a confirmed SARS-CoV-2 infection and either already have or get an ILR, PMK, or ICD device implanted. People with a history of AF, severe heart valve issues, kidney failure on dialysis, or conditions that could risk their safety can't join.Check my eligibility
What is being tested?
The study is tracking the progression of atrial fibrillation in patients who experienced it for the first time while hospitalized with COVID-19. It uses devices like ILRs (implantable loop recorders), PMKs (pacemakers), and ICDs (implantable cardioverter-defibrillators) to monitor heart rhythm continuously.See study design
What are the potential side effects?
While this study focuses on observation rather than treatment, implanting devices like ILRs, PMKs, and ICDs can cause risks such as infection at the site of implantation, bleeding, pain at the implant site, and potential malfunction of the device.
unCOVer-AF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
AF Burden
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
unCOVer-AF Trial Design
1Treatment groups
Experimental Treatment
Group I: COVID-19 patients with new-onset AFExperimental Treatment1 Intervention
Consecutive patients with a confirmed diagnosis of COVID-19 with a first clinical episode of AF at admission or during hospitalization.
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Who is running the clinical trial?
Texas Cardiac Arrhythmia Research FoundationLead Sponsor
37 Previous Clinical Trials
13,180 Total Patients Enrolled
26 Trials studying Atrial Fibrillation
6,445 Patients Enrolled for Atrial Fibrillation
Domenico G Della Rocca, MDStudy DirectorTexas Cardiac Arrhythmia Research Foundation
Andrea Natale, MDPrincipal InvestigatorTexas Cardiac Arrhythmia Research Foundation
35 Previous Clinical Trials
8,018 Total Patients Enrolled
26 Trials studying Atrial Fibrillation
7,239 Patients Enrolled for Atrial Fibrillation
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have tested positive for the COVID-19 virus.You have a history of atrial fibrillation or flutter, no matter what kind it is.You have a moderate to severe narrowing of the mitral valve in your heart.You have a certain heart condition called atrial fibrillation that lasts for more than 30 seconds.You have permanent kidney failure and need dialysis.You have a mechanical heart valve.You have had a heart device implanted during or shortly after being hospitalized for COVID-19, or before being hospitalized for COVID-19.
Research Study Groups:
This trial has the following groups:- Group 1: COVID-19 patients with new-onset AF
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any more opportunities for enrollment in the trial?
"Affirmative. The information on clinicaltrials.gov confirms that this medical investigation, which was initially launched on April 15th 2021, is actively recruiting participants. Around 200 people must be enrolled from 3 distinct research centres."
Answered by AI
How many participants are actively enrolled in this research endeavor?
"To successfully conduct the trial, 200 qualified subjects are required. Participants can come from two different locations - Texas Cardiac Arrhythmia Institute in Austin or Kansas City Heart Rhythm Institute in Overland Park."
Answered by AI
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