reMARQable nMARQ™ Pulmonary Vein Isolation System for the Treatment of Paroxysmal Atrial Fibrillation
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 481
- 主要终点
- Incidence of Early Onset Primary Adverse Events for the Intent-to-Treat and As-Treated Population
研究概览
简要总结
To demonstrate safety and effectiveness of nMARQ Catheter System [nMARQ] compared with THERMOCOOL® Navigational Family of catheters in treating subjects with drug-refractory symptomatic paroxysmal atrial fibrillation (PAF).
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
- •Patients with symptomatic paroxysmal AF who have had at least one AF episode documented within one (1) year prior to enrollment. Documentation may include ECG, transtelephonic monitor (TTM), Holter monitor (HM), or telemetry strip.
- •Patients who have failed at least one antiarrhythmic drug (AAD; class I or III, or atrioventricular (AV) nodal blocking agents such as beta blockers and calcium channel blockers) as evidenced by recurrent symptomatic AF, or intolerance to the AAD.
- •Pre-procedure anticoagulation on warfarin, rivaroxaban, or apixaban.
- •Age 18 years or older.
- •Signed Patient Informed Consent Form (ICF).
- •Able and willing to comply with all pre-, post-, and follow-up testing and requirements.
排除标准
- •AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
- •Previous ablation for atrial fibrillation.
- •Patients on amiodarone at any time during the past 3 months prior to enrollment.
- •AF episodes lasting > 7 days.
- •Any cardiac surgery within the past 60 days (2 months).
- •Any valvular cardiac surgical procedure (i.e., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve).
- •Coronary artery bypass graft (CABG) procedure within the last 180 days (6 months).
- •Awaiting cardiac transplantation or other cardiac surgery within the next 365 days (12 months).
- •Documented left atrial thrombus on imaging.
- •History of a documented thromboembolic event within the past one (1) year.
- •Diagnosed atrial myxoma.
- •Presence of implanted cardioverter defibrillator (ICD).
- •Significant pulmonary disease, (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms.
- •Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study.
- •Women who are pregnant (as evidenced by pregnancy test if subject is of child-bearing age and potential) or breast feeding.
- •Acute illness or active systemic infection or sepsis.
- •Unstable angina.
- •Myocardial infarction within the previous 60 days (2 months).
- •Left ventricular ejection fraction <40%.
- •History of blood clotting or bleeding abnormalities.
- •Contraindication to anticoagulation (i.e., heparin, dabigatran, Vitamin K Antagonists such as warfarin).
- •Life expectancy less than 365 days (12 months).
- •Enrollment in an investigational study evaluating another device or drug.
- •Uncontrolled heart failure or NYHA Class III or IV heart failure.
- •Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation.
- •Presence of a condition that precludes vascular access.
- •Left atrial size >50 mm.
结局指标
主要结局
Incidence of Early Onset Primary Adverse Events for the Intent-to-Treat and As-Treated Population
时间窗: 30 days post-procedure
The primary safety endpoint was the incidence of early-onset primary adverse events within 7 days post the AF ablation procedure; Pulmonary vein stenosis and atrio-esophageal fistula that occurred beyond 7 days post-procedure and development of a significant pericardial effusion within 30 days post-procedure were also considered primary AEs
Number of Participants With Early Onset Primary Adverse Events
时间窗: 30 days post-procedure
The primary safety endpoint was the incidence of early-onset primary adverse events within 7 days post the AF ablation procedure; Pulmonary vein stenosis and atrio-esophageal fistula that occurred beyond 7 days post-procedure and development of a significant pericardial effusion within 30 days post-procedure were also considered primary AEs
次要结局
未报告次要终点