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

RECRUITING

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.

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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).

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

AF first diagnosed within 2 years prior to enrolment and documented in body surface ECG

High comorbidity estimated by CHA2DS2-VASc score of 4 or more

Patient suitable for ablation using cryoballoon ablation systems from Medtronic

Age ≥ 18 years

Provision of signed informed consent

Exclusion criteria

Any disease that limits life expectancy to less than 1 year.

Participation in another clinical trial, either within the 3 months prior to enrolment or still on-going (participation in potential sub-studies connected to this trial is permitted).

Previous participation in EASThigh-AFNET 11.

Pregnant women.

Breastfeeding women.

Drug abuse or clinically manifest alcohol abuse.

Prior AF ablation or surgical therapy of AF.

Patients not suitable for AF ablation.

Patients with a history of stroke which occurred within 3 months prior to enrolment.

Valve disease requiring specific therapy.

Clinically manifested thyroid dysfunction requiring therapy.

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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

Trial ID

NCT06324188

Intervention or treatment

OTHER: Early atrial fibrillation ablation

OTHER: Usual Care

Conditions

• Atrial Fibrillation

Condition: Atrial Fibrillation
OTHER: Early atrial fibrillation ablation and other drugs
Multiple Locations, Not Specified, Australia
Sponsor: Atrial Fibrillation Network

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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 Not Specified	OTHER: Early atrial fibrillation ablation Patients randomised to early atrial fibrillation ablation will undergo pulmonary vein isolation within 2 months after randomisation.
OTHER: Usual Care Not Specified	OTHER: Usual 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.

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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References

Clinical Trials Gov: Early Atrial Fibrillation Ablation for Stroke Prevention in Patients with High Comorbidity Burden (EASThigh-AFNET 11)