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Procedure
Early Ablation for Atrial Fibrillation
N/A
Recruiting
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
No Placebo-Only Group
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ throughout study completion, estimated at a mean of 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout study completion, estimated at a mean of 4 years
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Usual CareExperimental Treatment1 Intervention
Group II: Early atrial fibrillation ablationExperimental Treatment1 Intervention
Find a Location
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
Andreas Rillig, PD Dr.Study DirectorUniversity Heart and Vascular Center Hamburg, University Hospital Hamburg Eppendorf
Antonia Zapf, Prof. Dr.Principal InvestigatorInstitute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf
Prash Sanders, Prof. Dr.Principal InvestigatorCentre for Heart Rhythm Disorders, University of Adelaide, Royal Adelaide Hospital
Volker StraubPrincipal InvestigatorPatient representative
2 Previous Clinical Trials
1,200 Total Patients Enrolled
Jason Andrade, Prof. Dr.Principal InvestigatorUniversity of British Columbia, Vancouver General Hospital, Department of Electrophysiology
André Ng, Prof. Dr.Principal InvestigatorDepartment of Cardiovascular Sciences, University of Leicester