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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

    Study type

    PREVENTION

    phase

    Phase

      NA

    trial

    Trial ID

    NCT06324188

    Intervention or treatment

    OTHER: Early atrial fibrillation ablation

    OTHER: Usual Care

    Conditions

    • Atrial Fibrillation
    Image related to Atrial Fibrillation
    • Condition: Atrial Fibrillation

    • OTHER: Early atrial fibrillation ablation and other drugs

    • Multiple Locations, Not Specified, Australia

    • Sponsor: Atrial Fibrillation Network

    Find a site

    Closest Location:

    Several sites

    Research sites nearby

    Select from list below to view details:

    • Several sites

      Multiple Locations, Not Specified, Australia

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    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/ArmIntervention/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 MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Composite of cardiovascular complications related to AFIt 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 MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Number of nights spent in hospitalNot SpecifiedThroughout study completion, estimated at a mean of 4 years
    Time from randomisation to first occurrence of each of the individual components of the primary outcomeNot SpecifiedThroughout study completion, estimated at a mean of 4 years
    All-cause deathNot SpecifiedThroughout study completion, estimated at a mean of 4 years
    Serious adverse events related to AF therapyNot SpecifiedThroughout study completion, estimated at a mean of 4 years
    Time from randomisation to first cardiovascular hospitalisationNot SpecifiedThroughout study completion, estimated at a mean of 4 years
    Number of cardiovascular hospitalisations (over-night stay)Not SpecifiedThroughout study completion, estimated at a mean of 4 years
    Changes in left ventricular ejection fractionNot Specifiedcomparing baseline with 24 months follow up (FU)
    Changes in quality of lifeassessed by EQ-5D-5Lcomparing baseline with 12 and 24 months FU
    Changes in quality of lifeassessed by AFEQTcomparing baseline with 12 and 24 months FU
    Changes in cognitive functionassessed by Montreal-Cognitive-Assessment-Testcomparing baseline with 24 months FU
    Cardiac rhythm statussinus rhythm compared to AFat 12 and 24 months FU
    AF patternNot Specifiedat 12 and 24 months FU
    Time from randomisation to first clinical recurrence of AFNot SpecifiedThroughout study completion, estimated at a mean of 4 years
    Time from randomisation to first progression of AFi. e. from paroxysmal to persistent or longstanding persistent or permanent and each of these componentsThroughout study completion, estimated at a mean of 4 years

    Frequently Asked Questions

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    References

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

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