Comparison of the PolarX and the Arctic Front Cryoballoon for Pulmonary Vein Isolation in Patients With Symptomatic Paroxysmal Atrial Fibrillation - A Multi-Center Non-Inferiority Design Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 202
- 试验地点
- 4
- 主要终点
- Time to first recurrence of any atrial tachyarrhythmia
研究概览
简要总结
Pulmonary vein isolation (PVI) is an effective treatment for atrial fibrillation (AF). Single shot devices are increasingly used for PVI. Currently, Medtronic Arctic Front cryoballoon is the most frequently used single shot technology and hence is the benchmark for upcoming technologies. A novel cryoballoon technology has recently been introduced (PolarX, Boston Scientific). However, whether PolarX provides effectiveness similar to the standard-of-practice Medtronic Arctic Front cryoballoon is yet to be investigated. Given that PolarX was developed considering the reported limitations and potential failures associated with the Medtronic Arctic Front cryoballoon, it might be even more effective and safe for use in AF ablation procedures.
The aim of this trial is to compare the efficacy and safety of the PolarX Cryoballoon (Boston Scientific) and the Arctic Front Cryoballoon (Medtronic) in patients with symptomatic paroxysmal AF undergoing their first PVI.
This is an investigator-initiated, multicenter, randomized controlled, open-label trial with blinded endpoint adjudication. Given that the Medtronic Arctic Front Cryoballoon is the standard-of-practice for single shot PVI and the PolarX is the novel technology, this trial has a non-inferiority design.
The hypothesis with regards to the primary efficacy endpoint is that the PolarX Cryoballoon (Boston Scientific) shows lower efficacy compared to the Arctic Front Cryoballoon (Medtronic) and that therefore more episodes of first recurrence of any atrial arrhythmia between days 91 and 365 will be observed in patients with symptomatic paroxysmal AF undergoing their first PVI. Hence the alternative hypothesis postulates that the PolarX Cryoballoon is non-inferior to the Arctic Front Cryoballoon. Rejection of the null hypothesis is needed to conclude non-inferiority.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Paroxysmal atrial fibrillation documented on a 12 lead electrocardiogram (ECG) or Holter monitor (lasting ≥30 seconds) within the last 24 months. According to current guidelines, paroxysmal is defined as any atrial fibrillation (AF) that converts to sinus rhythm within 7 days either spontaneously or by pharmacological or electrical cardioversion.
- •Candidate for ablation based on current AF guidelines
- •Continuous anticoagulation with warfarin (International Normalized Ratio [INR] 2-3) or a novel oral anticoagulant (NOAC) for ≥4 weeks prior to the ablation; or a transesophageal echocardiogram (TEE) that excludes left atrial (LA) thrombus ≤48 hours before ablation
- •Age of 18 years or older on the date of consent
- •Informed Consent as documented by signature (Appendix Informed Consent Form)
排除标准
- •Previous LA ablation or LA surgery
- •AF due to reversible causes (e.g. hyperthyroidism, cardiothoracic surgery)
- •Intracardiac thrombus
- •Pre-existing pulmonary vein stenosis or pulmonary vein stent
- •Pre-existing hemidiaphragmatic paralysis
- •Contraindication to anticoagulation or radiocontrast materials
- •Cardiac valve prosthesis
- •Clinically significant (moderately-severe or severe) mitral regurgitation or stenosis
- •Myocardial infarction, percutaneous coronary intervention (PCI)/ percutaneous transluminal coronary angioplasty (PTCA), or coronary artery stenting during the 3-month period preceding the consent date
- •Cardiac surgery during the three-month interval preceding the consent date or scheduled cardiac surgery/transcatheter aortic valve implantation (TAVI) procedure
- •Significant congenital heart defect (including atrial septal defects or pulmonary vein abnormalities but not including patent foramen ovale)
- •New York Heart Association (NYHA) class III or IV congestive heart failure
- •Left ventricular ejection fraction (LVEF) <35%
- •Hypertrophic cardiomyopathy (wall thickness >1.5 cm)
- •Significant chronic kidney disease (CKD; estimated glomerular filtration rate [eGFR] <30 μMol/L)
- •Uncontrolled hyperthyroidism
- •Cerebral ischemic event (stroke or TIA) during the six-month interval preceding the consent date
- •Ongoing systemic infections
- •History of cryoglobulinemia
- •Pregnancy*
- •Life expectancy less than one (1) year per physician opinion
- •Currently participating in any other clinical trial of a drug, device or biological material during the duration of this study.
- •Unwilling or unable to comply fully with study procedures and follow-up.
- •To exclude pregnancy a blood test (human chorionic gonadotropin [HCG]) is used.
研究组 & 干预措施
PVI using the Arctic Front Cryoballoon (Medtronic)
Pulmonary vein isolation using the Arctic Front Cryoballoon (Medtronic)
干预措施: PVI using the Arctic Front Cryoballoon (Medtronic) (Device)
PVI using the PolarX Cryoballoon (Boston Scientific)
Pulmonary vein isolation using the PolarX Cryoballoon (Boston Scientific)
干预措施: PVI using the PolarX Cryoballoon (Boston Scientific) (Drug)
结局指标
主要结局
Time to first recurrence of any atrial tachyarrhythmia
时间窗: days 91 to 365 post-ablation
Time to first recurrence of any atrial tachyarrhythmia (atrial fibrillation \[AF\], atrial flutter \[AFL\] or atrial tachycardia \[AT\]) between days 91 and 365 post ablation as detected on continuous implantable cardiac monitor (ICM). AF, AFL or AT will qualify as a recurrence after ablation if it lasts 120 s or longer on ICM (the minimum programmable episode interval).
Number of Patients With Recurrence of Any Atrial Tachyarrhythmia
时间窗: days 91 to 365 post-ablation
Number of patients with recurrence of any atrial tachyarrhythmia (atrial fibrillation \[AF\], atrial flutter \[AFL\] or atrial tachycardia \[AT\]) between days 91 and 365 post ablation as detected on continuous implantable cardiac monitor (ICM). AF, AFL or AT will qualify as a recurrence after ablation if it lasts 120 s or longer on ICM (the minimum programmable episode interval).
次要结局
- Total LA indwelling time(Day 1)
- Number of participants with complications(days 0 to 30 post-ablation)
- Total procedure time(Day 1)
- Total cryoablation time(Day 1)
- Total number of cryoapplications per patient/per vein(Day 1)
- Time to effect(Day 1)
- Nadir temperatures(Day 1)
- Total fluoroscopy time(Day 1)
- Radiation dose(Day 1)
- Proportion of veins with PV signals visible before cryoablation(Day 1)
- Contrast agent usage(Day 1)
- Changes in high sensitive Troponin (hsTroponin)(Day 1)
- Time to first symptomatic recurrence of atrial tachyarrhythmia(between 91-365 days after ablation)
- Proportion of patients admitted to the hospital or emergency room because of documented recurrence of atrial arrhythmias(postablation 3 months (+/- 2 weeks), 12 months (+/- 2 months), 24 months (+/- 2 months) and 36 months (+/- 2 months))
- Sites (anatomical location) of vein reconnection assessed in study patients undergoing a Redo-Procedure at one of the study centres(during redo-procedure)
- Rate of Phrenic nerve palsy(Day 1)
- Time to first recurrence of atrial tachyarrhythmia(between days 1 and 90 after ablation)
- Comparison of the prevalence of the type of arrhythmia(3, 12, 24 and 36 months follow up)
- Proportion of patients undergoing electrical cardioversion because of documented recurrence of atrial arrhythmias(postablation 3 months (+/- 2 weeks), 12 months (+/- 2 months), 24 months (+/- 2 months) and 36 months (+/- 2 months))
- Arrhythmia burden (daily AF burden [hours/day]; overall AF burden = % time in AF)(between: 0-90 days; 91-365 days , 365 days up to 3.5 years)
- Arrhythmia burden calculated for 7-day intervals (daily AF burden [hours/day]; overall AF burden = % time in AF)(3, 6 and 12 months follow up)
- Number of reconnected veins assessed in study patients undergoing a Redo-Procedure at one of the study centres(during redo-procedure)
- Size (area calculate in mm2) of antral scar area assessed in study patients undergoing a Redo-Procedure at one of the study centres(during redo-procedure)
- Proportion of patients undergoing a repeat ablation procedure because of documented recurrence of atrial arrhythmias(postablation 3 months (+/- 2 weeks), 12 months (+/- 2 months), 24 months (+/- 2 months) and 36 months (+/- 2 months))
- Evolution of Quality of Life (QoL)(Months 3, 12, 24 and 36 post procedure)
- Nadir Temperatures(Day 1)
- Total Fluoroscopy Time(Day 1)
- Radiation Dose(Day 1)
- Number of Participants With Complications(days 0 to 30 post-ablation)
- Total Procedure Time(Day 1)
- Total Left Atrial (LA) Indwelling Time(Day 1)
- Total Cryoablation Time(Day 1)
- Total Number of Cryoapplications Per Patient/Per Vein(Day 1)
- Time to Effect(Day 1)
- Contrast Agent Usage(Day 1)
- Number of Patients With Veins With PV Signals Visible Before Cryoablation(Day 1)
- Number of Participants With Phrenic Nerve Palsy(Day 1)
- Number of Patients With Recurrence of Atrial Tachyarrhythmia(between days 1 and 90 after ablation)
- Overall AF Burden = % Time in AF(91-365 days)
- Number of Hospital Admissions or Emergency Room Visits Because of Documented Recurrence of Atrial Arrhythmias(Day 0 (after ablation) until day 365 post-ablation)
- Number of Electrical Cardioversion Because of Documented Recurrence of Atrial Arrhythmias(Day 0 (post-ablation) to day 365 after ablation)
- Number of Repeat Ablation Procedure Because of Documented Recurrence of Atrial Arrhythmias(Day 1 - 365 postablation)
- Evolution of Quality of Life (QoL)(Change in score from BL to 12 months)