Safety and Efficacy of New, Non-thermal Ablation Techniques for the Treatment of Atrial Fibrillation - A Comparison of Two Ablation Systems
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Primary outcome: Freedom from arrhythmia
研究概览
简要总结
Two non-thermal ablation techniques approved for routine clinical practice (CE-marked) for the interventional treatment of atrial fibrillation are compared in a 1:1 randomization to investigate patient data, procedural data, effectiveness, and safety.
详细描述
Patients with paroxysmal atrial fibrillation were randomized 1:1 to undergo pulmonary vein isolation using pulsed field ablation (PFA) with either single-shot PFA (FARAPULSE) or single-tip PFA (Galvanize Therapeutics). Baseline characteristics, procedural data, effectiveness, and safety outcomes were analyzed. In each group, a subset of consecutive patients underwent cerebral magnetic resonance imaging to assess silent cerebral lesions and was scheduled for biomarker assessment (blood sampling) to evaluate inflammation and troponin release after PFA.
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
- Single (Participant)
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
- •Recurrent, symptomatic paroxysmal atrial fibrillation
- •Age > 18 years
- •Patient consen
排除标准
- •Refusal of the patient
- •Inability to provide informed consent
- •Life expectancy < 2 years
- •Pregnancy and breastfeeding (due to radiation exposure)
- •History of left atrial ablation
- •Known macro-reentry or focal atrial tachycardia
- •Significant mitral valve stenosis
- •History of heart valve replacement or reconstruction
- •NYHA class III and IV
- •Left ventricular ejection fraction < 35%
- •Left atrial enlargement > 55 mm on echocardiography
- •Intracardiac thrombus prior to the procedure
- •Severe pulmonary disease with abnormal blood gases or requiring oxygen therapy
- •Renal insufficiency (GFR < 30 mL/min) due to contrast medium use
- •Stroke or TIA within the last 6 months
- •Symptomatic carotid stenosis
- •Active malignancy within the previous 24 months
- •Untreated or uncontrolled thyroid disease
- •Active bleeding or chronic bleeding tendency not amenable to curative treatment
- •Body mass index > 35 kg/m²
- •Contraindication to CT examination (e.g., contrast medium allergy or severe claustrophobia)
结局指标
主要结局
Primary outcome: Freedom from arrhythmia
时间窗: 12 months follow-up
The clinical efficacy, e.g. freedom from atrial arrhythmias / atrial fibrillation is assessed by 5-7 day Holter Monitoring at 3, 6 and 12 months after the procedure. Any documented arrhythmia episode lasting \>30s was calculated as failure. A three months blanking period was considered.
次要结局
- Secondary outcomes: Complications, Silent cerebral lesions (cMRI) and biomarker assessments(6 weeks)
研究者
Kars Neven
MD, PhD.
Alfried Krupp Krankenhaus