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Procedure

Early atrial fibrillation ablation for Atrial Fibrillation

N/A
Waitlist Available
Led By Jason Andrade, 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

Study 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.Check my eligibility
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.See study design
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
AF pattern
All-cause death
Cardiac rhythm status
+10 more

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
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any ongoing efforts to enroll participants for this research study at the moment?

"As per clinicaltrials.gov, recruitment for this particular trial has ceased. The trial was posted on June 1st, 2024, with the last update made on March 19th, 2024. However, it is worth noting that there are a substantial number of 491 ongoing trials actively seeking participants presently."

Answered by AI
Recent research and studies
New England Journal of MedicineJournal
Cryoablation or Drug Therapy for Initial Treatment of Atrial Fibrillation
Andrade, Jason G., George A. Wells, Marc W. Deyell, Matthew Bennett, Vidal Essebag, Jean Champagne, Jean-Francois Roux, et al.. 2021. “Cryoablation or Drug Therapy for Initial Treatment of Atrial Fibrillation”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa2029980.
clinicaltrials.govStudy
Early Atrial Fibrillation Ablation for Stroke Prevention in Patients With High Comorbidity Burden (EASThigh-AFNET 11)
2024. "Early Atrial Fibrillation Ablation for Stroke Prevention in Patients With High Comorbidity Burden (EASThigh-AFNET 11)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06324188.
~1541 spots leftby Feb 2030
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