High-Density Atrial Mapping After Pulsed Field Ablation (PFA): Development of an Algorithm to Predict Atrial Fibrillation (AF) Burden in Participants With Paroxysmal AF (PAF) and Persistent AF (PsAF) Treated With the VARIPULSE™ PFA Catheter
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 2,300
- 试验地点
- 1
- 主要终点
- Number of Participants with Early Onset Primary Adverse Events (PAEs)
研究概览
简要总结
The purpose of this study is to evaluate how safe VARIPULSE™ Catheter is and how well it works in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF; irregular heartbeat where episodes start and stop on their own, usually within seven days) and symptomatic persistent atrial fibrillation (PsAF; irregular, rapid heartbeat that lasts more than 7 days and doesn't stop on its own).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant has been diagnosed with either atrial fibrillation (AF) subtype (paroxysmal (AF episodes that start suddenly and typically last less than 7 days, often resolving in 24 hours) or persistent (AF lasting more than 7 days in duration and less than 365 days in duration, documented by )):
- •A physician's note documenting diagnosis of symptomatic PAF/PsAF, as defined above AND
- •PAF: At least one (1) AF episode electrocardiographically documented within 12 months prior to enrollment
- •PsAF: Two electrocardiograms (ECGs) showing continuous AF, with electrocardiogram taken at least 7 days apart (electrocardiograms cannot be more than (>) 365 days prior to enrollment) OR A 24-hour arrhythmia monitor documenting continuous AF within the last 365 days
- •Participant is aged 18-80 years at the time of informed consent
- •Participant is willing and capable of providing informed consent
- •Participant is able and willing to comply with all pre-, post-, and follow-up testing and requirements
排除标准
- •Participant has continuous AF > 365 days (longstanding persistent AF)
- •Participant has AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (for example, untreated documented obstructive sleep apnea, acute alcohol toxicity, et cetera)
- •Participant has previous surgical or catheter ablation for AF
- •Participant is known to require ablation outside the left atrium (LA), superior vena cava (SVC), and cavotricuspid isthmus (CTI) region (for example, atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, ventricular tachycardia and wolff-parkinson-white)
- •Participant has severe dilatation of the LA (LAD > 50 millimeter [mm]) of the antero-posterior diameter confirmed by imaging performed within 180 days prior to enrollment
- •Participant has LA thrombus confirmed by imaging within 48 hours prior to the procedure
- •Participant has severely compromised left ventricular ejection fraction (LVEF < 40 percent [%]) confirmed by imaging performed within 180 days prior to enrollment
- •Participant has uncontrolled heart failure or new york heart association (NYHA) Class III or IV
- •Participant has a history of blood clotting, bleeding abnormalities or contraindication to anticoagulation (for example, heparin)
- •Participant has had a thromboembolic event (including transient ischemic attack [TIA]) within 180 prior to enrollment
- •Participant has had a percutaneous coronary intervention or acute myocardial infarction (MI) within 60 days prior to enrollment
- •Participant has had coronary artery bypass grafting (CABG) surgery within 180 days prior to enrollment
- •Participant has had valvular cardiac surgical/percutaneous procedure (for example, ventriculotomy, atriotomy, valve repair or replacement, and presence of a prosthetic valve)
- •Participant has had unstable angina within 6 months prior to enrollment
- •Participant has anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 365 days post-procedure
- •Participant has significant pulmonary disease (for example, restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms
- •Participant has a significant congenital anomaly (for example, atrial septal defects [ASDs]) including repaired defects or medical problems that in the opinion of the Investigator would preclude enrollment in this study
- •Participant has an existing diagnosis of pulmonary vein stenosis (PVS)
- •Participant has a pre-existing hemi-diaphragmatic paralysis
- •Participant has an acute illness, active systemic infection, or sepsis
- •Participant has an intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation
- •Participant has severe mitral regurgitation (Regurgitant volume greater than or equal to (>=) 60 milliliter per beat (mL/beat), regurgitant fraction >= 50%, and/or effective regurgitant orifice area >=0.40 centimeter square [cm^2])
- •Participant has an implanted metal cardiac device, including MitraClip and left atrial appendage occlusion (LAAO) devices (for example, WATCHMAN, Amulet, et cetera.) (this exclusion does not include coronary stents, implanted pacemakers, implantable cardioverter-defibrillators (ICD), and an implantable loop recorders (ILR))
- •Participant has a condition that precludes vascular access (such as inferior vena cava (IVC) filter)
- •Participant is currently enrolled in another investigational device or drug study
- •Participant is pregnant, lactating, or is of child-bearing potential and plans on trying to become pregnant during the course of the clinical investigation
- •Participant has a life expectancy less than 365 days
研究组 & 干预措施
Paroxysmal Atrial Fibrillation (PAF)
Participants with symptomatic paroxysmal atrial fibrillation (PAF) undergoing first-time catheter ablation will be enrolled; and will undergo pulmonary vein isolation (PVI) utilizing the VARIPULSE catheter as per the device Instructions for Use (IFU).
干预措施: VARIPULSE Catheter System (PVI) (Device)
Persistent Atrial Fibrillation (PsAF)
Participants with symptomatic persistent atrial fibrillation (PsAF) undergoing first-time catheter ablation will be enrolled; and will undergo pulmonary vein isolation (PVI) and posterior wall isolation (PWI) utilizing the VARIPULSE catheter as per the device IFU.
干预措施: VARIPULSE Catheter System (PVI and PWI) (Device)
结局指标
主要结局
Number of Participants with Early Onset Primary Adverse Events (PAEs)
时间窗: Up to 7 days post-procedure
PAEs include early onset AEs such as: * Esophageal perforating complications * Phrenic nerve paralysis (PNP; permanent) * Cardiac tamponade/perforation * Pulmonary vein stenosis (PVS) * Death (device or procedure related) * Stroke/ cerebrovascular accident (CVA) * Major vascular access complication/bleeding * Thromboembolism * Myocardial Infarction (MI) * Transient ischemic attack (TIA) * Pericarditis * Pulmonary edema (respiratory insufficiency) * Heart block * Vagal nerve injury/ gastroparesis
Percentage of Participants With Residual Atrial Arrhythmia (AA) Burden Based on ILR Arrhythmia Monitoring
时间窗: Day 61 up to Day 365 post-procedure
Percentage of residual AA burden will be calculated as AA episodes over the monitoring time during the effectiveness evaluation period. Participants with residual AA burden less than or equal to (\<=) 0.1% and freedom from the following failure modes will be considered a success * Acute procedural failure * Repeat ablation failure * Surgical treatment for atrial fibrillation (AF)/atrial tachycardia (AT)/atrial flutter (AFL) after the index ablation procedure * Non-study catheter (NSC) failure * Antiarrhythmic Drug (AAD) failure or any direct current (DC) cardioversion (DCCV) procedure during the evaluation period.
次要结局
- Change in Quality of Life (QOL) As Assessed by the Atrial Fibrillation Effect on Quality-of-Life (AFEQT) score(Baseline to 12 months post-procedure)
- Freedom from Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia Episodes (12-Lead ECG or >=60 minutes on Implantable Loop Recorders [ILR])(Day 61 up to Day 365 post-procedure)
- Freedom from Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia Episodes (12-Lead ECG or >=30 seconds on ILR)(Day 61 up to Day 365 post-procedure)
- Number of Participants with Residual AA Burden <=0.1%(Day 61 up to Day 365 post-procedure)
- Percentage of Residual AA Burden(Day 61 up to Day 365 post-procedure)