PARALELL - Pulsed Field Ablation and Pulsed Field CRyoAbLation in PErsistent AtriaL FibrilLation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 89
- 试验地点
- 12
- 主要终点
- Primary Procedural Performance Outcome
研究概览
简要总结
A prospective, two-arm, multi-center, randomized, open-label, pre-market, First-in-Human clinical study designed to provide safety and performance data regarding the use of the Adagio PFA and PFCA Systems in the treatment of PsAF.
详细描述
Enrolled subjects will be treated (ablation) with the Adagio PFA or PFCA System in a 1:1 randomized fashion.
Treatment will include the isolation of pulmonary veins (PVIs), and isolation of the left atrial posterior wall (PWI), and CTI at the discretion and clinical judgment of the investigator.
Data will be collected throughout 12-month follow up period to assess safety and performance of the device. Recurrence of atrial arrhythmias is measured by 12-lead ECGs and 48-hour continuous ECG recording (Holter).
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
- •IC 1 Male or female between the ages of 18 - 80 years
- •IC 2 Currently scheduled for an ablation of symptomatic persistent (> 7 days) atrial fibrillation within the past year documented by ECG or Continuous Holter monitoring
- •IC 3 Refractory to at least one class I or III AAD. (Refractory defined as not effective or not tolerated)
- •IC 4 Willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full length of the study
- •IC 5 Willingness and ability to give an informed consent
排除标准
- •EC 1 In the opinion of the Investigator, any known contraindication to an atrial ablation, TEE, or anticoagulation. Including but not limited to the identification of any atrial thrombus or evidence of sepsis
- •EC 2 Continuous AF lasting longer than 12-months
- •EC 3 History of previous left atrial ablation or surgical treatment for AF/AFL/AT
- •EC 4 AF secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause
- •EC 5 Structural heart disease as described below:
- •Left ventricular ejection fraction (LVEF) < 40% based on most recent TTE
- •Left atrial size > 55 mm (parasternal long axis view) documented within 6-months of screening
- •NYHA Class III or IV heart failure documented within the previous 12-months
- •An implanted pacemaker or ICD
- •Previous cardiac surgery, ventriculotomy, or atriotomy (excluding atriotomy for CABG),
- •Previous cardiac valvular surgical or percutaneous procedure, or prosthetic valve
- •Interatrial baffle, closure device, patch, or PFO occluder
- •Presence of a left atrial appendage occlusion device
- •Presence of any pulmonary vein stenting devices
- •Coronary artery bypass graft (CABG) or PTCA procedure within six (6) months prior to procedure
- •Unstable angina or ongoing myocardial ischemia
- •Myocardial infarction within the previous six (6) months prior to procedure
- •Moderate or severe mitral insufficiency or stenosis based on most recent TTE
- •Atrial myxoma
- •Significant congenital anomaly
- •EC 6 BMI > 40
- •EC 7 Any previous history of cryoglobulinemia (for those patients randomized to the PFCA arm)
- •EC 8 History of blood clotting or bleeding disease
- •EC 9 History of severe COPD requiring steroid use in the previous 12-months
- •EC 10 History of severe sleep apnea (AHI > 30) not currently treated with a CPAP machine or other mechanical device
- •EC 11 Stroke or TIA within the last year.
- •EC 12 Any prior history or current evidence of hemidiaphragmatic paralysis
- •EC 13 Pregnant or lactating (current or anticipated during study follow-up
- •EC 14 Current enrollment in any other study protocol where testing or results from that study may interfere with the procedure or outcome measurements for this study
- •EC 15 Any other conditions such as, mental illness, addictive disease, terminal illness with a life expectancy of less than two years, extensive travel away from the research center that may lead to non-compliance with the protocol procedure or follow up
研究组 & 干预措施
Pulsed Field Ablation (PFA) group
PsAF patients treated by PFA
干预措施: Atrial ablation for subject scheduled for a de novo endocardial ablation of symptomatic, drug-refractory PsAF. (Device)
Pulsed Field CryoAblation (PFCA) group
PsAF patients treated by PFCA
干预措施: Atrial ablation for subject scheduled for a de novo endocardial ablation of symptomatic, drug-refractory PsAF. (Device)
结局指标
主要结局
Primary Procedural Performance Outcome
时间窗: Procedure
Analysis of the evidence of procedural electrical isolation of all pulmonary veins, posterior wall, and bidirectional block (if applicable) across all other ablation lines using the study device.
Primary Endpoint for Safety
时间窗: Up to 7 days following the ablation procedure
Analysis of the proportion of subjects who are free from device/procedure-related Major Adverse Events that occur during or following the ablation procedure
次要结局
- Procedural Performance - intraprocedural PV reconnection rate(procedure)
- One-Year Safety(12 months)
- Procedural Performance - ablation time(procedure)
- Procedural Performance - fluoroscopy time(procedure)
- One-Year Performance(12 months)
- Procedural Performance - procedure time(procedure)
- Procedural Performance - AAD use(procedure and up to 12-month)
- Procedural Performance - repeat ablation(procedure and up to 12-month)