PARALELL - Pulsed Field Ablation and Pulsed Field CRyoAbLation in PErsistent AtriaL FibrilLation
概览
- 阶段
- 不适用
- 干预措施
- Atrial ablation for subject scheduled for a de novo endocardial ablation of symptomatic, drug-refractory PsAF.
- 疾病 / 适应症
- Atrial Fibrillation
- 发起方
- Adagio Medical
- 入组人数
- 89
- 试验地点
- 12
- 主要终点
- Primary Procedural Performance Outcome
- 状态
- 已完成
- 最后更新
- 19天前
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).
研究者
入排标准
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),
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.
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.
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)