Comparison of Safety and Effectiveness of a VARIPULSE™ PFA Catheter to FARAWAVE™ PFA Catheter in the Treatment of Participants With Persistent Atrial Fibrillation: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 566
- 试验地点
- 36
- 主要终点
- Occurrence of Early Onset Primary Adverse Events (PAEs)
研究概览
简要总结
The purpose of this study is to assess how safe VARIPULSE pulsed field ablation (PFA) catheter is and how well it works compared to food and drug administration (FDA) approved FARAWAVE PFA catheter in participants with symptomatic persistent atrial fibrillation (PsAF; continuous irregular, rapid heartbeat that lasts over 7 days and doesn't stop on its own).
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 symptomatic persistent atrial fibrillation (PsAF), which is defined as continuous atrial fibrillation (AF) sustained beyond 7 days and less than 365 days in duration documented by: i. A physician's note documenting diagnosis of symptomatic PsAF as defined above and ii. Two electrocardiograms showing continuous AF, with electrocardiogram taken at least 7 days apart (electrocardiograms cannot be greater than [>] 365 days prior to enrollment) or iii. 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, etc.)
- •Participant has had previous surgical or catheter ablation for AF
- •Participant is known to require ablation outside the left atrium (LA), superior vena cava (SVC), and the 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 millimeters [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 less than [<] 40%) 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 TIA) within the past 180 days prior to enrollment
- •Participant has had a percutaneous coronary intervention or acute MI within past 60 days prior to enrollment
- •Participant has had coronary artery bypass grafting (CABG) surgery within the past 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 unstable angina within past 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 milliliters [mL]/beat, regurgitant fraction >= 50 percent [%], and/or effective regurgitant orifice area >= 0.40 square centimeter [cm^2])
- •Participant has an implanted metal cardiac device, including MitraClip and left atrial appendage occlusion (LAAO) devices (for example, WATCHMAN, Amulet, etcetra.) and/or a double-coiled implantable cardioverter-defibrillators (ICD), (this exclusion does not include coronary stents, implanted pacemakers, single-coiled ICD and implantable loop recorders [ILR])
- •Participant has a condition that precludes vascular access (such as inferior vena cava [IVC] filter)
- •Participant is currently enrolled in an investigational study evaluating another device or drug
- •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
- •For magnetic resonance imaging (MRI) subset:
- •Contraindication to use of contrast agents for MRI such as advanced renal disease etcetera
- •Presence of iron-containing metal fragments in the body that renders the participant contraindicated for an MRI
- •Unresolved pre-existing neurological deficit
研究组 & 干预措施
VARIPULSE Pulsed Field Ablation (PFA) Catheter
Participants with persistent atrial fibrillation (PsAF) undergoing catheter ablation will undergo the ablation procedure with VARIPULSE catheter, and will be followed for up to 12 months post procedure. Eligible participants may enter an magnetic resonance imaging (MRI) subset and undergo MRI assessments at baseline and post-ablation procedure.
干预措施: VARIPULSE Catheter (Device)
FARAWAVE PFA Catheter
Participants with PsAF undergoing catheter ablation will undergo the ablation procedure with FARAWAVE catheter, and will be followed for up to 12 months post procedure. Eligible participants may enter an MRI subset and undergo MRI assessments at baseline and post-ablation procedure.
干预措施: FARAWAVE Catheter (Device)
结局指标
主要结局
Occurrence of Early Onset Primary Adverse Events (PAEs)
时间窗: Up to 7 days post-index procedure
PAEs that 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, and vagal nerve injury/ gastroparesis.
Freedom from Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia Episodes
时间窗: Day 61 up to Day 180
Number of participants reporting freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmia (that is, atrial fibrillation or atrial tachycardia or atrial flutter \[AF, AT or AFL\] of unknown origin) episodes based on electrocardiographic data and freedom from acute procedural failure, repeat ablation failure, surgical treatment for AF/AT/AFL, non-study catheter (NSC) failure, antiarrhythmic drug (AAD) failure and any direct current cardioversion (DCCV) procedure.
Freedom from Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia Episodes
时间窗: Day 61 and onward
Number of participants reporting freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmia (that is, atrial fibrillation or atrial tachycardia or atrial flutter \[AF, AT or AFL\] of unknown origin) episodes based on electrocardiographic data and freedom from acute procedural failure, repeat ablation failure, surgical treatment for AF/AT/AFL, non-study catheter (NSC) failure, antiarrhythmic drug (AAD) failure and any direct current cardioversion (DCCV) procedure.
Time to Occurrence of Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia Episodes
时间窗: Day 61 and onward
Time to occurrence of documented (symptomatic and asymptomatic) atrial tachyarrhythmia (atrial fibrillation \[AF\], atrial tachycardia \[AT\] or atrial flutter \[AFL\] of unknown origin) episodes based on electrocardiographic data (12-Lead Electrocardiogram (ECG) or greater than equal to (\>=) 30 seconds on sponsor provided Cardiac Event Monitor (CEM) or Patch arrhythmia monitor) during the effectiveness evaluation period or acute procedural failure, repeat ablation failure, surgical treatment for AF/AT/AFL, non-study catheter (NSC) failure, antiarrhythmic drug (AAD) failure and any direct current cardioversion (DCCV) procedure.
次要结局
- Change From Baseline in Quality of life, As Measured by the Total Atrial Fibrillation Effect on Quality-of-Life (AFEQT) Score(Baseline, at 6 months and at 12 months post-index procedure)
- Change From Baseline in Quality of life, As Measured by the Total Atrial Fibrillation Effect on Quality-of-Life (AFEQT) Score(Baseline and at 6 months post procedure)