Multi-electrode Radiofrequency Balloon Catheter Use for the Isolation of the Pulmonary Veins.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 5
- 主要终点
- Number of Participants With Early Onset Primary Adverse Events (PAEs): Death, Atrio-esophageal Fistula and Pulmonary Vein Stenosis
研究概览
简要总结
This clinical investigation is a prospective, multicenter, single arm clinical evaluation utilizing the multi-electrode radiofrequency balloon catheter and the multi-electrode circular diagnostic catheter.
详细描述
The objective of this clinical investigation is to assess the safety and acute effectiveness of the multi-electrode radiofrequency balloon catheter and multi-electrode circular diagnostic catheter when used for the isolation of the pulmonary veins in the treatment of Paroxysmal Atrial Fibrillation (PAF).
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
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with Symptomatic Paroxysmal AF.
- •Selected for atrial fibrillation (AF) ablation procedure for pulmonary vein isolation.
- •Able and willing to comply with uninterrupted per-protocol anticoagulation requirements
- •Age 18-75 years.
- •Able and willing to comply with all pre-, post- and follow-up testing and requirements.
- •Signed Patient Informed Consent Form.
排除标准
- •AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
- •Previous surgical or catheter ablation for AF.
- •Anticipated to receive ablation outside the PV ostia and Cavo-triscuspid-isthmus (CTI) region
- •Previously diagnosed with persistent, longstanding AF and/or continuous AF > 7 days, or > 48 hrs terminated by cardioversion.
- •Any percutaneous coronary intervention (PCI) within the past 2 months.
- •Valve repair or replacement and presence of a prosthetic valve.
- •Any carotid stenting or endarterectomy.
- •Coronary artery bypass grafting (CABG), cardiac surgery (e.g. ventriculotomy, atriotomy), or valvular cardiac surgical or percutaneous procedure within the past 6 months.
- •Documented left atrium (LA) thrombus on baseline/pre-procedure imaging.
- •LA antero posterior diameter > 50 mm
- •Any PV with a diameter ≥ 26 mm
- •Left Ventricular Ejection Fraction (LVEF) < 40%.
- •Contraindication to anticoagulation (e.g. heparin).
- •History of blood clotting or bleeding abnormalities.
- •Myocardial infarction within the past 2 months.
- •Documented thromboembolic event [including transient ischemic attack(TIA)] within the past 12 months.
- •Rheumatic Heart Disease.
- •Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV.
- •Awaiting cardiac transplantation or other cardiac surgery within the next 12 months.
- •Unstable angina.
- •Acute illness or active systemic infection or sepsis.
- •Diagnosed atrial myxoma or interatrial baffle or patch.
- •Presence of implanted pacemaker or implantable 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 pre-menopausal), lactating, or who are of child bearing age and plan on becoming pregnant during the course of the clinical investigation.
- •Enrollment in an investigational study evaluating another device, biologic, or drug.
- •Has known pulmonary vein stenosis.
- •Presence of intramural thrombus, tumor or other abnormality that precludes vascular access, or manipulation of the catheter.
- •Presence of an Inferior Vena Cava (IVC) filter
- •Presence of a condition that precludes vascular access.
- •Life expectancy or other disease processes likely to limit survival to less than 12 months.
- •Presenting contra-indication for the devices (e.g. transthoracic echocardiography (TTE), CT, etc.) used in the study, as indicated in the respective instructions for use.
- •Categorized as a vulnerable population and requires special treatment with respect to safeguards of well-being
- •Additional exclusion criteria for Neurological Assessment Evaluable (NAE) subjects:
- •Contraindication to use of contrast agents for MRI such as advanced renal disease, etc. (at PI discretion)
- •Presence of iron-containing metal fragments in the body
- •Unresolved pre-existing neurological deficit.
结局指标
主要结局
Number of Participants With Early Onset Primary Adverse Events (PAEs): Death, Atrio-esophageal Fistula and Pulmonary Vein Stenosis
时间窗: Up to 90 days (post initial mapping and ablation procedure)
A Primary AEs is an event which occurred within 90 days following initial ablation procedure. Primary AEs included: Death, atrio-esophageal fistula, and pulmonary vein stenosis.
Number of Participants With Early Onset PAEs: Myocardial Infraction, Cardiac Tamponade/Perforation, Thromboembolism, Stroke/Cerebrovascular Accident, Transient Ischemic Attack, Phrenic Nerve Paralysis, and Major Vascular Access Complication/Bleeding
时间窗: Up to 7 days (post initial mapping and ablation procedure)
A Primary AEs is an event which occurred within the first week (7 days of the initial mapping and ablation procedure) which included myocardial infraction (MI), cardiac tamponade (CT)/perforation, thromboembolism, stroke/cerebrovascular accident (CVA), Transient ischemic attack (TIA), phrenic nerve paralysis (PNP), and major vascular access complication (MVAC)/bleeding following initial ablation procedure.
Percentage of Participants With Acute Procedural Success
时间窗: Day 1
Acute procedural success is defined as confirmation of entrance block in treated pulmonary veins (PV) after adenosine and/or isoproterenol challenge (with or without the use of a focal catheter).
次要结局
- Number of Participants With New or Worsening Neurologic Deficits(Pre-procedure, discharge, 1 Month, 3 Month and 6 Month)
- Number of Participants With NIHSS Scores(Pre-procedure and at discharge (Up to 405 Days))
- Number of Participants With Individual PAE From Primary Composite(Up to 7 days for MI, CT/perforation, thromboembolism, stroke/CVA, TIA, PNP and MVAC (initial mapping and ablation procedure) and up to 90 days for death, AE fistula, and PVST (post procedure))
- Number of Participants With Serious Adverse Device Effects (SADEs)(Up to 405 Days)
- Number of Participants With Serious Non-primary Adverse Events Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and Greater Than or Equal to (>=) 31 Days (Late Onset) of Initial Ablation Procedure(Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and >=31 Days (Late Onset) of Initial Ablation Procedure (Up to 405 Days))
- Number of Participants With Non-serious Adverse Events(Up to 405 Days)
- Number of Participants With Pre-and Post-ablation Asymptomatic and Symptomatic Cerebral Emboli(Pre-procedure, at Discharge, 1 Month and at unscheduled visit (Up to 405 Days))
- Number of Participants With Hospitalization for Cardiovascular Events(Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and >=31 Days (Late Onset) of Initial Ablation Procedure (Up to 405 Days))
- Percentage of Participants With Use of Focal Catheter Ablation for Non-PV Triggers(Up to 405 Days)
- Percentage of Participants With Freedom From Documented Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atypical (Left Side) Atrial Flutter (AFL) Episodes or Documented Symptomatic AF/AT/AFL(Up to 6 Months)
- Percentage of Participants With Freedom From Documented, AF, AT, or Atypical (Left Side) AFL Episodes or Documented Symptomatic AF/AT/AFL(Up to 12 Months)
- Number of Participants With Symptomatic and Asymptomatic Cerebral Emboli(Up to 405 Days)
- Number of Participants With MoCA Scores(Up to 405 Days)
- Percentage of Participants With PVI Touch-up by Balloon and/or Focal Catheter Among All Targeted Veins and by Participants(Up to 405 Days)