A Clinical Trial for the Assessment of the Safety and Performance of the Vimecon Laser Cardiac Ablation Instrument (CAI) for the Interventional Treatment of Paroxysmal Atrial Fibrillation (AF)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 3
- 主要终点
- Safety assessment, free of any Major Adverse Events's or safety events within the first three (3) months after the treatment..
研究概览
简要总结
This study is a prospective, non-randomized, single arm, multicenter, CE marking trial for patients with paroxysmal atrial fibrillation to undergo an ablation of the cardiac tissue near the PV.
详细描述
The objective of this clinical investigation is to confirm the safety and performance of the Vimecon® Laser Cardiac Ablation Instrument when creating scar tissue within the cardiac wall for the treatment of atrial fibrillation.
Up to 66 patients with paroxysmal atrial fibrillation refractory to at least one antiarrhythmic medications (Class I or III) are enrolled. with an expected 10% dropout; 59 per protocol patients are required.
The study duration will be 18 month with a 6 month enrollment period and 12 month follow-up. Interim follow-up visits are at post procedure, 1 Month, 3 Months, 6 Months and 12 Months.
The baseline and follow up tests are standard of care. Additional optional tests are an esophageal endoscopy for determination of potential fistula formation and a cerebral MRI for micro embolism post treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 75 years.
- •Patients with intention to be treated for paroxysmal atrial fibrillation. AND unresponsive to ≥1 antiarrhythmic drug (class I or III) AND at least 2 episodes in the last 12 months, 1 of them documented.
- •Patient should be on an anticoagulation therapy according to the international guidelines (per ACC/AHA//ESC Practice Guidelines)
- •Left atrial (LA) size < 50 mm
- •Symptomatic AF (EHRA-Score ≥ 2)
- •Accessibility of femoral vein and pulmonary veins
- •All patients willing to comply with the study protocol for at least 12 months
排除标准
- •Inability to give written informed consent
- •NYHA Class III and IV
- •Hyperthyroidism
- •Reversible causes of the AF like Pericarditis, Electrolytic imbalance
- •Left Atrial Thrombus formation
- •Structural heart disease disturbing accessibility for AF ablation.
- •Valvular AF, permanent and long-standing persistent AF, currently present Atrial Flutter
- •Any valvular dysfunction more than II°
- •Systemic infections or endocarditis.
- •Impaired left ventricular function with an ejection fraction of less than 35%
- •Kidney dysfunction >Class III with a GFR of less than 35 mL per minute
- •TIA or stroke within the last 6 months
- •Pregnant and breastfeeding Women
- •Previous relevant cardiac surgery (e.g. ASD, PFO, Maze, AICD, pacemaker, congenital heart disorders or valve replacement).
- •Previous ablation of the pulmonary vein.
- •Known or suspected atrial myoma
- •Subject has co-morbid conditions that place the subject at an unacceptable risk (e.g., severe chronic obstructive pulmonary disease, hepatic failure, cerebral degenerative diseases, immunosuppressive abnormalities, hypercoagulable state, nervous system disease and hematological abnormalities.)
- •Contraindicated for the protocol defined anticoagulation plan (per ACC/AHA//ESC Practice Guidelines)
- •Patients with known allergic reactions to the local anesthetic, sedatives, x-ray dye, heparin, protamine, components of the catheter (platinum, iridium, stainless steel) or other agents administered during the procedure.
- •AV-Block IIº and IIIº
- •Contraindication for femoral vein and pulmonary veins access (e.g.: femoral Stent graft, excessive calcification, previous surgical interventions in or adjacent to the femoral veins that impede femoral access)
- •Contraindications for the transseptal approach (e.g.: previous inter-atrial septal patch or surgical interventions in or adjacent to the intro atrial septum)
- •MI in the last 3 months.
- •Enrolled in another clinical trial with a non-CE marked device which has not yet reached its primary endpoint
研究组 & 干预措施
Vimecon Laser CAI Cardiac Ablation
Ablation of the cardiac tissue by the use of the Vimecon Laser CAI (Cardiac Ablation Instrument).
干预措施: Vimecon Laser CAI percutaneous cardiac ablation (Procedure)
结局指标
主要结局
Safety assessment, free of any Major Adverse Events's or safety events within the first three (3) months after the treatment..
时间窗: < month-3
Safety: • Evaluating the proportion of subjects free from experiencing Serious Adverse Events related to the catheter ablation procedure (Major Adverse Events's or safety events) within the first three (3) months after the treatment. Major adverse events (MAE, Safety events) associated with the catheter ablation procedure include: * Cardiac tamponade * Thromboembolic events including pulmonary embolism and stroke * Complete heart block * Acute myocardial infarction * Phrenic nerve palsy * Atrio-esophageal fistula * Vascular complications * Death
次要结局
未报告次要终点