Evaluation of QDOT MICRO™ Catheter for Pulmonary Vein Isolation (PVI) in Subjects With PAF
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 283
- 试验地点
- 22
- 主要终点
- Percentage of Participants With Early Onset Primary Adverse Events (PAEs): Atrio-esophageal Fistula and Pulmonary Vein (PV) Stenosis
研究概览
简要总结
Prospective, non-randomized, pre-market clinical evaluation of the QDOT MICRO™ Catheter to demonstrate the safety and effectiveness when compared to an historical control performance goal.
详细描述
Prospective, non-randomized, pre-market clinical evaluation of the QDOT MICRO™ Catheter to demonstrate the safety and effectiveness when compared to an historical control performance goal.
the trial has two arms: main arm and second arm (variable flow). The main arm will enroll 185 subjects and second arm will enroll 92 subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •Symptomatic paroxysmal AF with one electrocardiographically documented AF episode within 6 months prior to enrollment and a a physician's note indicating recurrent self-terminating AF within 7 days . Documentation may include electrocardiogram (ECG); Transtelephonic monitoring (TTM), Holter monitor or telemetry strip.
- •Failed at least one Class I or Class III antiarrhythmic drug as evidenced by recurrent symptomatic AF, contraindicated, or intolerable to the AAD.
- •Age 18 years or older.
排除标准
- •Previous surgical or catheter ablation for atrial fibrillation.
- •AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
- •Previously diagnosed with persistent or long-standing persistent AF and/or Continuous AF > 7 days.
- •Valve repair or replacement or presence of a prosthetic valve.
- •CABG surgery within the past 6 months (180 days).
- •Any carotid stenting or endarterectomy within the past 6 months.
- •Coronary artery bypass grafting, cardiac surgery, or valvular cardiac surgical procedure within the past 6 months.
- •Documented left atrium (LA) thrombus within 1 day prior to the index procedure.
- •Documented LA size > 50 mm.
- •Documented LVEF < 40%.
- •Contraindication to anticoagulation (e.g., heparin).
- •MI/PCI within the past 2 months.
- •Documented thromboembolic event (including transient ischemic attack) within the past 12 months.
- •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.
- •Presence of implanted pacemaker or implantable cardioverter defibrillator (ICD).
- •Women who are pregnant, lactating, or who are of child bearing age and plan on becoming pregnant during the course of the clinical investigation.
研究组 & 干预措施
Main Arm
Subjects will be ablated with the QDOT Micro Catheter for Pulmonary Vein Isolation with nMARQ RF Generator
干预措施: RF Ablation with QDOT Micro (Device)
Second Arm (variable flow)
subjects will be treated with QDOT Micro catheter with variable flow nMARQ RF generator
干预措施: RF Ablation with QDOT Micro (Device)
结局指标
主要结局
Percentage of Participants With Early Onset Primary Adverse Events (PAEs): Atrio-esophageal Fistula and Pulmonary Vein (PV) Stenosis
时间窗: Up to 90 days (post initial and repeated ablation procedure)
An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. A Primary AEs is an event which occurred within 90 days following initial and repeated ablation procedure using the QDOT MICRO. Primary AEs included: atrio-esophageal fistula and pulmonary vein stenosis.
Percentage of Participants With Freedom From Documented Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes or Other Failure Modes
时间窗: Day 91 to Day 365
Percentage of participants with freedom from documented AF, AT, or AFL episodes or following failure modes: a) Acute procedural: Failure to confirm entrance block in all pulmonary veins post-procedure and use of a non-study catheter to treat left atrial ablation targets and Cavo-tricuspid isthmus; b) Repeat ablation: \>2 repeat ablation procedures with the study catheter during the 3-Month blanking period (Day 0-90) after the index ablation procedure, use of a non-study catheter to treat study arrhythmia ablation targets during the blanking period, and any repeat ablation procedure during the Evaluation Period; c) Antiarrhythmic drug: taking a new AAD for AF or a previously failed AAD at a greater than the highest ineffective historical dose for AF during the evaluation period, were reported.
Percentage of Participants With Early Onset PAEs: Death, Myocardial Infraction, Cardiac Tamponade/Perforation, Thromboembolism, Stroke/Cardiovascular Accident , TIA, PNP, Heart Block, Pulmonary Edema, Vagal Nerve Injury, Pericarditis, and MVAC/Bleeding
时间窗: Up to 7 days (post initial and repeated ablation procedure)
A Primary AEs is an event which occurred within the first week (7 days of the initial and repeated ablation procedure) which included death, myocardial infraction (MI), cardiac tamponade (CT)/perforation, thromboembolism, stroke/cardiovascular accident (CVA), transient ischemic attack (TIA), phrenic nerve paralysis (PNP), heart block, pulmonary edema, vagal nerve injury, pericarditis, and major vascular access complication/bleeding (MVAC).
次要结局
- Percentage of Targeted Veins With Touch-up (Ablation of Acute Reconnection) Among All Targeted Veins(Up to 20 months)
- Percentage of Participants Requiring New Linear Lesion and/or New Foci Identified During the Repeat Ablation Procedure(Up to 20 months)
- Percentage of Participants With Electrical Isolation of Pulmonary Veins (PVs) (Entrance Block) at the End of the Procedure(End of the Procedure (up to 20 months))
- Percentage of Participants With Electrical Isolation of PV After First Encirclement With Acute Reconnection(Up to 20 months)
- Number of Participants With Serious Non-Primary Adverse Events (SAEs) 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 20 months))
- Number of Participants With Bleeding Complication by International Society on Thrombosis and Haemostasis (ISTH) Class and Timing of Onset(Within 7 days (early onset), 8-30 days (peri-procedural) and >=31 days (late onset) of initial ablation procedure (up to 20 months))
- Percentage of Participants With Pulmonary Veins (PV) Touch-up(Up to 20 months)
- Number of Participants With Unanticipated Adverse Device Effects (UADEs)(Up to 20 months)
- Percentage of Participants With Touch-up at Anatomical Location of Acute PV Reconnection After First Encirclement(Up to 20 months)
- Percentage of Participants Who Underwent Repeat Ablation Procedures(Up to 20 months)
- Percentage of Participants With Electrical Isolation of PV After First Encirclement Without Acute Reconnection(Up to 20 months)
- Percentage of Participants With PVs Re-isolation Among All of the Targeted PVs at Repeat Procedure(Up to 20 months)
- Percentage of Participants With 12-Month Single Procedure Success(Up to 12 months)