At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Early atrial fibrillation ablation (other), Usual Care (other)
- How long the study runs
- Study runs about 67 months (dates as stated)
- About the drug or intervention
- Early atrial fibrillation ablation — other: Patients randomised to early atrial fibrillation ablation will undergo pulmonary vein isolation within 2 months after randomisation. · Usual Care — other: 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.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, called EASThigh-AFNET 11, looks at people with atrial fibrillation (an irregular heart rhythm) that was first diagnosed within the last 5 years. It is testing whether having early ablation treatment (a procedure to correct the heart rhythm) can help prevent strokes in patients who have other long-term health conditions. The study is run by the Atrial Fibrillation Network.
Who can take part
- Atrial fibrillation first diagnosed within the past 5 years and confirmed on a heart tracing (ECG)
- A high level of other health conditions, measured by a heart risk score called CHA2DS2-VASc of 4 or more
- Suitable for ablation treatment using a freezing balloon system or a similar system made by Medtronic
- Aged 18 or over
- Able to give signed informed agreement to take part
Who may not be able to
- Any illness that limits life expectancy to less than 1 year
- Taking part in another clinical trial in the past 3 months, or one that is still running (the study's own sub-studies are allowed)
- Having taken part in this study before
- Pregnant or breastfeeding women
- Drug misuse or clear alcohol misuse
- Previous ablation or surgery for atrial fibrillation
- Not suitable for atrial fibrillation ablation
- A stroke within the 3 months before joining
- Heart valve disease needing specific treatment
- An over- or under-active thyroid problem that needs treatment
What taking part involves
- • Ablation treatment, which may use a freezing balloon (cryoballoon) system or a comparable Medtronic system
Time commitment: Not stated — ask the trial team about how many visits there are, how long the study lasts, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 2,312
- Started
- 2024-10-14
- Last checked
- 2025-11
Plain English Summary
What is this study?
- • Testing a new treatment for atrial fibrillation
- • NA - 2,312 participants
- • EASThigh-AFNET 11 is an international, prospective, randomized, open, blinded endpoint assessment, multicenter trial (Treatment Strategy trial)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with atrial fibrillation
Where?
- • Multiple Locations - Several sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
Atrial Fibrillation (AF) is associated with high morbidity and mortality. Even on optimal anticoagulation and therapy of concomitant conditions, many patients with AF suffer cardiovascular events, especially heart failure events, stroke, and cardiovascular death. Most of these events occur in elderly patients with comorbidities. Early rhythm control, mainly delivered using antiarrhythmic drugs, reduces AF-related complications when added to anticoagulation, rate control, and treatment of comorbidities when compared to current practice that offers rhythm control mainly to reduce symptoms. The outcome-reducing effect of early rhythm control is most pronounced in patients with multiple comorbidities, quantified by a CHA2DS2-VASc score ≥ 4. Attaining sinus rhythm is the key mediator for the outcome-reducing effect of early rhythm control. Atrial fibrillation ablation controls the rhythm better than drug-based rhythm control, avoids long-term antiarrhythmic drug treatment, thus reducing polypharmacy, and may therefore be the ideal rhythm control treatment in patients with AF and a high comorbidity burden. This hypothesis needs testing. The investigator-initiated EASThigh-AFNET 11 trial evaluates the effectiveness and safety of early atrial fibrillation ablation in patients with recently diagnosed AF and a high comorbidity burden. EASThigh-AFNET 11 is a Treatment Strategy trial randomizing 2312 patients with AF and a high comorbidity burden to early atrial fibrillation ablation or usual care to achieve a fixed number of primary endpoint events of n=527. All therapies are clinically approved. The primary outcome is a composite of cardiovascular death, stroke, and hospitalization for worsening of heart failure. The primary safety outcome is a composite of all-cause death and serious complications of AF therapy. Secondary outcome parameters address safety, patient reported outcomes and cognitive function. EASThigh-AFNET 11 was recommended for funding by the Expert Advisory Panel of the Global Cardiovascular Research Funders Forum (GCRFF).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓I1. AF first diagnosed within 5 years prior to enrolment and documented in body surface ECG
- ✓I2. High other health condition estimated by CHA2DS2-VASc score of 4 or more
- ✓I3. Patient suitable for ablation using cryoballoon ablation systems or other ablation systems with comparable...
- ✓I4. Age ≥ 18 years
- ✓I5. Provision of signed agreement to take part
Who cannot take part
- ✗General exclusion criteria
- ✗E1. Any disease that limits life expectancy to less than 1 year.
- ✗E2. Participation in another clinical trial, either within the 3 months prior to enrolment or still on-going...
- ✗E3. Previous participation in EASThigh-AFNET 11.
- ✗E4. Pregnant women.
See the full criteria
Where Is This Study? (1 UK site)
Several sites
Multiple Locations, United Kingdom
How to Get in Touch
Antje Albring, Dr.
Sponsor contactCONTACT
Anna-Katharina Quade
Sponsor contactCONTACT