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Early Atrial Fibrillation Ablation for Stroke Prevention in Patients with High Comorbidity Burden (EASThigh-AFNET 11)
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.
Study details:
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).
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-10-14
Primary completion: 2030-02-01
Study completion finish: 2030-05-01
Study type
PREVENTION
Phase
NA
Trial ID
NCT06324188
Intervention or treatment
OTHER: Early atrial fibrillation ablation
OTHER: Usual Care
Conditions
- • Atrial Fibrillation
Find a site
Closest Location:
Several sites
Research sites nearby
Select from list below to view details:
Several sites
Multiple Locations, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
OTHER: Early atrial fibrillation ablation
| OTHER: Early atrial fibrillation ablation
|
OTHER: Usual Care
| OTHER: Usual Care
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Composite of cardiovascular complications related to AF | It is defined as time from randomisation to the first occurrence of a composite of cardiovascular death, stroke (either ischemic or hemorrhagic), or hospitalisation for worsening of heart failure. | Throughout study completion, estimated at a mean of 4 years |
The primary safety outcome is a composite of all-cause death and serious complications of AF therapy. | Serious Adverse Events (SAEs), including primary and secondary outcome parameters if based on clinical events, will be adjudicated by the independent Clinical Event Committee (CEC) according to standardised definitions given in the CEC charter. | Throughout study completion, estimated at a mean of 4 years |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Number of nights spent in hospital | Not Specified | Throughout study completion, estimated at a mean of 4 years |
Time from randomisation to first occurrence of each of the individual components of the primary outcome | Not Specified | Throughout study completion, estimated at a mean of 4 years |
All-cause death | Not Specified | Throughout study completion, estimated at a mean of 4 years |
Serious adverse events related to AF therapy | Not Specified | Throughout study completion, estimated at a mean of 4 years |
Time from randomisation to first cardiovascular hospitalisation | Not Specified | Throughout study completion, estimated at a mean of 4 years |
Number of cardiovascular hospitalisations (over-night stay) | Not Specified | Throughout study completion, estimated at a mean of 4 years |
Changes in left ventricular ejection fraction | Not Specified | comparing baseline with 24 months follow up (FU) |
Changes in quality of life | assessed by EQ-5D-5L | comparing baseline with 12 and 24 months FU |
Changes in quality of life | assessed by AFEQT | comparing baseline with 12 and 24 months FU |
Changes in cognitive function | assessed by Montreal-Cognitive-Assessment-Test | comparing baseline with 24 months FU |
Cardiac rhythm status | sinus rhythm compared to AF | at 12 and 24 months FU |
AF pattern | Not Specified | at 12 and 24 months FU |
Time from randomisation to first clinical recurrence of AF | Not Specified | Throughout study completion, estimated at a mean of 4 years |
Time from randomisation to first progression of AF | i. e. from paroxysmal to persistent or longstanding persistent or permanent and each of these components | Throughout study completion, estimated at a mean of 4 years |
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