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
- 41
- 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.
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 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 Targeted Veins With Touch-up (Ablation of Acute Reconnection) Among All Targeted Veins(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 Requiring New Linear Lesion and/or New Foci Identified During the Repeat Ablation Procedure(Up to 20 months)
- Percentage of Participants With 12-Month Single Procedure Success(Up to 12 months)