Sinus Rhythm Maintenance in Patients With Hypertrophic Cardiomyopathy and Atrial Fibrillation - Randomized Comparison of Antiarrhythmic Therapy vs. Radiofrequency Catheter Ablation (SHAARC)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Efficacy: Freedom from atrial fibrillation and atrial flutter (>1 min) on or off antiarrhythmic medications.
研究概览
简要总结
Paroxysmal or chronic atrial fibrillation (AF) develops in about 20- 25% of adult patients with hypertrophic cardiomyopathy (HCM) and represents an important complication in the clinical course of the disease, with adverse long-term consequences on functional status and outcome.
Therefore, aggressive therapeutic strategies are indicated to restore and maintain sinus rhythm (SR) in patients with HCM. Nevertheless, pharmacologic prevention of AF recurrence is challenging because of the limited long-term efficacy and potentially hazardous side effects of available treatment options. Currently radiofrequency catheter ablation (RFCA) of AF is successfully used in clinical practice. However, comparison of the efficacy and safety of these two therapeutic options has not been done up till now in randomized manner in this group of patients.
Thus, the aim of the present study is to compare the efficacy and safety of RFCA vs. antiarrhythmic drug therapy in patients with HCM and 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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with hypertrophic cardiomyopathy and paroxysmal or chronic atrial fibrillation
排除标准
- •Severe hear failure (NYHA IV)
- •Left ventricular ejection fraction <0.30
- •Left atrial diameter >65 mm
- •Age > 70 years
- •Contraindication to anticoagulation with warfarin
- •Presence of a mechanical prosthetic valve
- •Presence of left atrial thrombus on TEE or CT
- •Woman currently pregnant
- •Renal failure (GFR < 30 ml/min)
- •Hepatic failure
- •Untreated hypothyroidism or hyperthyroidism
- •LVOT gradient > 50 mmHg
研究组 & 干预措施
RFCA
干预措施: RF catheter ablation (Procedure)
Drug
干预措施: Antiarrhythmic drugs (Drug)
结局指标
主要结局
Efficacy: Freedom from atrial fibrillation and atrial flutter (>1 min) on or off antiarrhythmic medications.
时间窗: 1 year
次要结局
- Changes in symptom severity and quality of life.(1 year)
- Changes in total symptomatic and asymptomatic AF burden.(1 year)
- Incidence of complications.(1 year)
- Changes in level of Nt-pro-BNP.(1 year)
- Changes in left atrial diameter and left ventricular function.(1 year)
- Changes in exercise capacity assessed by cardiopulmonary exercise testing.(1 year)