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Procedure

Early Ablation for Atrial Fibrillation

N/A
Waitlist Available
Led By Kevin Vernooy, Prof. Dr.
Research Sponsored by Atrial Fibrillation Network
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 throughout study completion, estimated at a mean of 4 years
Awards & highlights

Summary

This trial aims to study whether performing early atrial fibrillation ablation in patients with atrial fibrillation and other health issues can reduce the occurrence of stroke, cardiovascular death, or heart failure events compared

Who is the study for?
This trial is for patients with atrial fibrillation who also have other health conditions that increase their risk of stroke and heart issues (CHA2DS2-VASc score of 4 or higher). Specific eligibility details are not provided, but typically participants must meet certain health standards to be included.
What is being tested?
The EASThigh-AFNET 11 study is testing if doing an early procedure called atrial fibrillation ablation can prevent strokes and other heart problems better than the usual care given for high-risk AF patients.
What are the potential side effects?
While specific side effects are not listed, generally, atrial fibrillation ablation may cause complications like bleeding, infection at the catheter site, damage to blood vessels or heart tissue. Usual care side effects depend on the treatments used.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout study completion, estimated at a mean of 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout study completion, estimated at a mean of 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Composite of cardiovascular complications related to AF
The primary safety outcome is a composite of all-cause death and serious complications of AF therapy.
Secondary study objectives
Cardiac rhythm status
Changes in cognitive function
Changes in quality of life
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Usual CareExperimental Treatment1 Intervention
Group II: Early atrial fibrillation ablationExperimental Treatment1 Intervention

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Who is running the clinical trial?

Atrial Fibrillation NetworkLead Sponsor
15 Previous Clinical Trials
24,266 Total Patients Enrolled
13 Trials studying Atrial Fibrillation
20,776 Patients Enrolled for Atrial Fibrillation
Kevin Vernooy, Prof. Dr.Principal InvestigatorDepartment of Cardiology, Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Center (MUMC)
Paulus Kirchhof, Prof. Dr.Study DirectorUniversity Heart and Vascular Center Hamburg, University Hospital Hamburg Eppendorf
2 Previous Clinical Trials
4,156 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
1,548 Patients Enrolled for Atrial Fibrillation
~1541 spots leftby Feb 2030
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