Prospective Multicenter Randomized and Controlled Study Evaluating the Benefit of Early Pulmonary Vein Isolation Compared to Usual Treatment in Patients Aged Over 75 Years and Presenting With Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 294
- 试验地点
- 1
- 主要终点
- Time before occurrence of the first event among cardiovascular death, hospitalization (all causes) and stroke
研究概览
简要总结
Therapeutic management of Atrial Fibrillation (AF) is based either on heart rate control or on rhythm control, a strategy which aims to maintain a normal heart rhythm. The benefit in terms of morbidity and mortality of a normal heart rhythm would, however, be largely offset by the frequent side effects of antiarrhythmic drugs which could even lead to an increase in mortality compared to rate control. This increase has particularly been suggested in people aged over 75.
Since the emergence of catheter Pulmonary Vein Isolation (PVI), an effective alternative to antiarrhythmic drugs has become available. This technique makes it possible to isolate the foci triggering AF under local or general anesthesia with greater effectiveness than medications and very low risks. Records in the elderly do not seem to show a reduction in effectiveness or an increase in complications. However, in the absence of a dedicated randomized study, its use is strongly limited in the elderly where rate control (52% of people over 65 years old) and the use of antiarrhythmic drugs are largely favored due to the simplicity of implementation and the low cost of medications.
However, an early rhythm control strategy seems to reduce cardiovascular events in relatively old individuals (average age 70 years). The use of PVI in first line could make it possible to further improve these results.
The objective of the investigator is therefore to carry out the first randomized comparative study proposing to evaluate the impact of early PVI compared to usual treatment in patients aged 75 and over with AF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Man or woman aged 75 and over.
- •Paroxysmal AF or early recurrent or persistent paroxysmal AF first diagnosed less than 12 months ago.
- •Patient who consented to participate in the study.
- •Patient affiliated to a social security system.
排除标准
- •Indication of cardiac pacing or defibrillation at baseline.
- •History of valve replacement, atrial occlusion or exclusion.
- •History of AF ablation.
- •Contraindication to anticoagulation or an invasive procedure.
- •Significant heart disease (structural with alteration of LVEF <35%, congenital heart disease, hypertrophic heart disease with wall of more than 15 mm, revascularized coronary syndrome less than 3 months old).
- •Stroke less than 6 months old.
- •Uncontrolled dysthyroidism.
- •Chronic renal failure (CKD - eGFR <30 µMol/L).
- •Patient under curatorship, guardianship, safeguard of justice.
- •Life expectancy less than 24 months.
- •Participation in another therapeutic trial likely to impact the study evaluation criteria.
- •Severe cognitive impairment noted in history.
- •Lack of understanding of the study.
研究组 & 干预措施
Rhythm control by Pulmonary Vein Isolation (PVI) procedure
干预措施: Rhythm control by Pulmonary Vein Isolation (PVI) procedure (Procedure)
Conventional care by antiarrhythmic drugs or bradycardic drugs
干预措施: Conventional care by antiarrhythmic drugs (flecainide, sotalol, amiodarone) or bradycardic drugs (all betablocker or calcium channel blocker therapy, digoxin) (Drug)
结局指标
主要结局
Time before occurrence of the first event among cardiovascular death, hospitalization (all causes) and stroke
时间窗: 2 years
Days
次要结局
- Number of patients treated by cardiovascular drugs(2 years)
- Number of PVI peri-procedural complications(48 hours)
- Number of documented episodes of AF(2 years)
- Autonomy score(24 months)
- Physical performance score(2 years)
- Evolution of IADL score according to the results of the ICOPE test at inclusion(2 years)
- Cognitive assessment(2 years)
- Number of complications(2 years)
- Quality of life score(24 months)
- Doses of cardiovascular drugs(2 years)
- Body weight(24 months)
- Numbers of falls(24 months)
- Evolution of ADL score according to the results of the Integrated Care for Older People (ICOPE) test at inclusion(2 years)