Workflow Study of the VARIPULSE™ Catheter With the TRUPULSE™ Generator for Treatment of Paroxysmal Atrial Fibrillation (PAF) or Persistent Atrial Fibrillation (PsAF) With the New VARIPULSE™ Pro Software
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 12
- 主要终点
- Total Procedure Time
研究概览
简要总结
The main purpose of this clinical study is to investigate the effectiveness workflow of the clinical use of the pulsed field (PF) ablation system (VARIPULSE™ Catheter and TRUPULSE™ Generator) when used for cardiac ablation with the new VARIPULSE™ Pro software in participants with paroxysmal atrial fibrillation (PAF; irregular heartbeat where episodes start and stop on their own, usually within seven days) and persistent atrial fibrillation (PsAF; irregular, rapid heartbeat that lasts over 7 days up to 1year and doesn't stop on its own).
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 persistent atrial fibrillation (PsAF) or paroxysmal atrial fibrillation (PAF)
- •Selected to undergo an ablation procedure for management of their arrhythmia by pulmonary vein isolation (PVI) only or PVI only with cavotricuspid isthmus (CTI) dependent atrial flutter ablation
- •Failed at least one antiarrhythmic drug (AAD; class I to IV) as evidenced by recurrent symptomatic atrial fibrillation (AF), or intolerable or contraindicated to the AAD
- •Age 18-75 years
- •Willing and capable of providing consent
- •Able and willing to comply with all pre-, post- and follow-up testing and requirements
排除标准
- •Continuous AF greater than (>) 12 months (1-Year) (Longstanding Persistent AF)
- •Previous surgical or catheter ablation for atrial fibrillation
- •Any cardiac surgery within the past 2 months (60 days prior to consent date) (includes percutaneous coronary intervention [PCI])
- •Previous coronary artery bypass grafting (CABG) in conjunction with valvular surgery, cardiac surgery (for example, ventriculotomy, atriotomy) or valvular cardiac (surgical or percutaneous) procedure
- •Any carotid stenting or endarterectomy
- •Presence of left atrium (LA) thrombus
- •Severe dilatation of the LA (left atrial diameter [LAD] >50 millimeters [mm] antero-posterior diameter in case of transthoracic echocardiography [TTE])
- •Severely compromised left ventricular ejection fraction (LVEF less than [<] 40 percent [%])
- •Known significant pulmonary vein (PV) anomaly that in the opinion of the investigator would preclude enrollment in this study
- •Prior diagnosis of pulmonary vein stenosis
- •Pre-existing hemi diaphragmatic paralysis
- •History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran)
- •Myocardial infarction (MI) within the past 2 months (60 days prior to consent date)
- •Documented thromboembolic event (including transient ischemic attack [TIA]) within the past 6 months [180 days prior to consent date])
- •Rheumatic Heart Disease
- •Uncontrolled heart failure or New York heart association (NYHA) function class III or IV
- •Severe mitral regurgitation
- •Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months
- •Unstable angina pectoris within the past 6 months prior to consent date
- •Acute illness or active systemic infection or sepsis
- •Previously known AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (for example, documented obstructive sleep apnea, acute alcohol toxicity, morbid obesity [Body Mass Index >40 kilogram per meter square {kg/m^2}], renal insufficiency (with an estimated creatinine clearance < 30 milliliters per minute {mL/min}/1.73 m^2)
- •Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch, prosthetic valve or other abnormality that precludes catheter introduction or manipulation
- •Presence of intramural thrombus, tumor or other abnormality that precludes vascular access, or manipulation of the catheter
- •Presence of any other condition that precludes appropriate vascular access (such as inferior vena cava [IVC] filter)
- •Significant pulmonary disease, (for example, restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease [COPD]) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms
- •Significant congenital anomaly or medical problems 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 childbearing age and plan on becoming pregnant during the course of the clinical investigation
- •Current enrollment in an investigational study evaluating another device, biologic, or drug
- •Presenting contra-indications for the devices used in the study, as indicated in the respective instructions for use (IFU)
- •Categorized as vulnerable population and requiring special treatment with respect to safeguards of well-being
- •Life expectancy less than 12 months
- •Contraindication for MRI such as use of contrast agents due to advanced renal disease, claustrophobia, implantable pacemakers, implantable cardioverter/defibrillators (ICDs),etc. (at principal investigator [PI] discretion)
- •Presence of iron-containing metal fragments in the body
- •Unresolved pre-existing neurological deficit
研究组 & 干预措施
Pulsed Field Ablation: VARIPULSE Catheter with TRUPULSE Generator and VARIPULSE Pro Software
Participants undergoing cardiac ablation for management of treatment of symptomatic Persistent Atrial Fibrillation (PsAF) or Paroxysmal Atrial Fibrillation (PAF) will undergo pulsed field ablation (PFA) with the VARIPULSE Catheter and the TRUPULSE Generator with the new VARIPULSE Pro software.
干预措施: Pulsed Field Ablation System (Device)
结局指标
主要结局
Total Procedure Time
时间窗: Intraoperative
The total procedure time will be reported.
Number of PF applications by Pulmonary Vein (PV)
时间窗: Intraoperative
Number of PF applications by PV will be reported.
Number of PF applications by Other Cardiac Locations
时间窗: Intraoperative
Number of PF applications by other cardiac locations will be reported.
Number of PF applications by Participant
时间窗: Intraoperative
Number of PF applications by participant will be reported.
Pulmonary Vein Isolation (PVI) Time
时间窗: Intraoperative
Time to PVI will be reported.
Total Fluoroscopy Time
时间窗: Intraoperative
The total time that fluoroscopy/ X-Ray system used during the ablation procedure will be reported.
Total Study Catheter Left Atrial Dwell Time
时间窗: Intraoperative
The total study catheter left atrial dwell time (that is time between the ablation catheter entering the left atrium to its withdrawal from the left atrium) will be reported.
Pulsed Field (PF) Application Time
时间窗: Intraoperative
PF application time will be reported.
Acute Effectiveness
时间窗: Intraoperative
Acute effectiveness, that is, acute procedural success, which is defined as electrical isolation of clinically relevant targeted PVs (confirmed by entrance block) after adenosine/isoproterenol challenge at the end of the index ablation procedure will be reported.
Pulmonary Vein Isolation (PVI) Durability
时间窗: At 3 months post index ablation procedure
PVI durability is defined as sustained isolation of pulmonary vein (PVs) that are targeted in the index ablation procedure, which is evidenced by the confirmation of isolation via the electro-anatomical mapping 90 (+/- 14 days) days post index ablation procedure.
Number of PF applications by PV
时间窗: Intraoperative
Number of PF applications by PV will be reported.
Tissue Proximity Indication (TPI)
时间窗: Intraoperative
TPI will be reported.
次要结局
- Occurrence of Serious Adverse Device Effects (SADE; Within Seven [7] Days of Index Ablation Procedure) Where the Investigational Devices were Used per Clinical Investigation Plan(Up to 7 days post index ablation procedure)
- Occurrence of Unanticipated Serious Adverse Device Effects (USADEs)(Up to 3 months post index ablation procedure)
- Occurrence of SAEs(At 7 days, 8 to 30 days (peri-procedural) and Up to 3 months post index ablation procedure)
- Occurrence of Non-Serious Adverse Events (Non-SAEs)(Up to 3 months post index ablation procedure)
- Number of Participants with PVI Durability(Up to 90 days post index ablation procedure)
- Occurrence of Serious Adverse Device Effects (SADE) (Within Seven (7) days) of Index Ablation Procedure) Where the Investigational Devices were Used per Clinical Investigation Plan(Up to 7 days post index ablation procedure)
- Occurrence of SAEs(At 7 days, 8 to 30 days (peri-procedural) and up to 3 months post index ablation procedure)
- Occurrence of New Post-Ablation Asymptomatic and Symptomatic Cerebral Emboli Observed Post-Ablation as Determined by Magnetic Resonance Imaging (MRI) Evaluations(Up to 3 months post index ablation procedure)
- Anatomical Location of New Post-Ablation Asymptomatic and Symptomatic Cerebral Emboli Observed Post-Ablation as Determined by MRI Evaluations(Up to 3 months post index ablation procedure)
- Size of New Post-Ablation Asymptomatic and Symptomatic Cerebral Emboli Observed Post-Ablation as Determined by MRI Evaluations(Up to 3 months post index ablation procedure)
- Occurrence of New or Worsening Neurological Deficits(Up to 3 months post index ablation procedure)
- Mini Mental State Examination (MMSE)(Baseline up to 3 months post index ablation procedure)
- National Institutes of Health Stroke Scale (NIHSS)(Baseline up to 3 months post index ablation procedure)
- Modified Rankin Scale (mRS)(Baseline up to 3 months post index ablation procedure)
- Occurrence of Severe Pulmonary Vein (PV) Stenosis(Up to 3 months post index ablation procedure)