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RecruitingNot ApplicableNCT06324188

Early Atrial Fibrillation Ablation for Stroke Prevention in Patients With High Comorbidity Burden (EASThigh-AFNET 11)

Sponsor

Atrial Fibrillation Network

Enrollment

2,312 participants

Start Date

Oct 14, 2024

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation

Summary

EASThigh-AFNET 11 is an international, prospective, randomized, open, blinded endpoint assessment, multicenter trial (Treatment Strategy trial). The objective of EASThigh-AFNET 11 is to investigate whether early atrial fibrillation ablation in patients with atrial fibrillation (AF) and a high comorbidity burden (CHA2DS2-VASc ≥4) reduces cardiovascular events (stroke, cardiovascular death, or heart failure events) compared to usual care.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether performing a heart procedure called catheter ablation early in people with atrial fibrillation (an irregular heartbeat) and serious health conditions can help prevent strokes. You may be eligible if... - You are 18 or older - You were first diagnosed with atrial fibrillation within the last 5 years - You have a high risk score for stroke (CHA2DS2-VASc of 4 or more) - You are a suitable candidate for a catheter ablation procedure You may NOT be eligible if... - You have a life-threatening illness expected to last less than 1 year - You have had a previous ablation or surgery for atrial fibrillation - You had a stroke within the past 3 months - You have thyroid problems, serious valve disease, drug or alcohol abuse issues - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHEREarly atrial fibrillation ablation

Patients randomised to early atrial fibrillation ablation will undergo pulmonary vein isolation within 2 months after randomisation.

OTHERUsual Care

Usual care will consist of optimal AF therapy based on guideline recommendations and local protocols and usage.The choice of therapies and medications follows routine care in line with medical guidelines and local policies at the discretion of the treating physician and should be based on the individual medical status of each study patient.

Locations(7)

Several sites

Multiple Locations, Australia

Several sites

Multiple Locations, Canada

Several sites

Multiple Locations, Germany

Several sites

Multiple Locations, Netherlands

Several sites

Multiple Locations, Poland

Several sites

Multiple Locations, Spain

Several sites

Multiple Locations, United Kingdom

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NCT06324188

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