Early Atrial Fibrillation Ablation for Stroke Prevention in Patients With High Comorbidity Burden (EASThigh-AFNET 11)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,312
- 试验地点
- 8
- 主要终点
- The primary safety outcome is a composite of all-cause death and serious complications of AF therapy.
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
blinded endpoint assessment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AF first diagnosed within 5 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 or other ablation systems with comparable efficacy and safety from Medtronic
- •Age ≥ 18 years
- •Provision of signed informed consent
排除标准
- •General 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
- •Pregnant women.
- •Breastfeeding women.
- •Drug abuse or clinically manifest alcohol abuse.
- •Exclusion criteria related to a cardiac condition
- •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.
- •Exclusion criteria based on laboratory abnormalities
- •Clinically manifested thyroid dysfunction requiring therapy.
研究组 & 干预措施
Usual Care
干预措施: Usual Care (Other)
Early atrial fibrillation ablation
干预措施: Early atrial fibrillation ablation (Other)
结局指标
主要结局
The primary safety outcome is a composite of all-cause death and serious complications of AF therapy.
时间窗: Throughout study completion, estimated at a mean of 4 years
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.
Composite of cardiovascular complications related to AF
时间窗: Throughout study completion, estimated at a mean of 4 years
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.
次要结局
- Number of cardiovascular hospitalisations (over-night stay)(Throughout study completion, estimated at a mean of 4 years)
- Changes in left ventricular ejection fraction(comparing baseline with 24 months follow up (FU))
- Number of nights spent in hospital(Throughout study completion, estimated at a mean of 4 years)
- Time from randomisation to first cardiovascular hospitalisation(Throughout study completion, estimated at a mean of 4 years)
- AF pattern(at 12 and 24 months FU)
- All-cause death(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(Throughout study completion, estimated at a mean of 4 years)
- Serious adverse events related to AF therapy(Throughout study completion, estimated at a mean of 4 years)
- Changes in cognitive function(comparing baseline with 24 months FU)
- Cardiac rhythm status(at 12 and 24 months FU)
- Time from randomisation to first clinical recurrence of AF(Throughout study completion, estimated at a mean of 4 years)
- Time from randomisation to first progression of AF(Throughout study completion, estimated at a mean of 4 years)
- Changes in quality of life(comparing baseline with 12 and 24 months FU)