NCT07523620招募中不适用
Comprehensive LEFt Atrial Appendage Occlusion With Rhythm Restoration
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 16
研究概览
简要总结
The objective of this clinical investigation is to evaluate the feasibility, safety, and effectiveness of a concomitant procedure involving the Volt PFA System and Amulet 2 device in patients indicated for both AF ablation and percutaneous LAAO.
详细描述
This clinical investigation is intended to evaluate the safety and feasibility of Abbott's Volt™ Pulsed Field Ablation (PFA) System (Volt PFA System) and Amulet™ 2 Left Atrial Appendage (LAA) occluder device (Amulet 2 device) in patients with non-valvular atrial fibrillation who are indicated for both atrial fibrillation (AF) ablation and LAA occlusion (LAAO)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Subject must provide written informed consent prior to any clinical investigation-related procedure.
- •18 years of age or older, or the age of legal consent
- •CHA2DS2-VASc score of ≥ 3 for women and ≥ 2 for men
- •Able to stop anticoagulation by 90 days post index procedure
- •Able to adhere to the protocol defined post-concomitant procedure pharmacologic regimen of OAC for at least 60 days followed by SAPT
- •Plans to undergo a catheter ablation procedure including PVI due to symptomatic, recurrent, drug-refractory PAF or PersAF
- •Documented symptomatic PAF or PersAF. Documentation requirements are as follows:
- •Paroxysmal:
- •Physician's note indicating recurrent self-terminating AF with ≥ 2 episodes of PAF within the 12 months prior to enrollment AND
- •One electrocardiographically documented PAF episode within 12 months prior to enrollment.
- •Persistent: Continuous AF sustained beyond 7 days and less than 1 year that is documented by
- •Physician's note, AND either
- •24-hour Holter within 180 days prior to enrollment, showing continuous AF, OR
- •Two electrocardiograms (from any form of rhythm monitoring) showing continuous AF:
- •That are taken at least 7 days apart but less than 12 months apart
- •If electrograms are more than 12 months apart, there must be one or more Sinus Rhythm recordings in between or within 12 months prior to consent/enrollment
- •The most recent electrocardiogram must be within 180 days of enrollment.
- •NOTE: Documented evidence of the AF episode must either be continuous AF on a 12-lead ECG or include at least 30 seconds of continuous AF from another ECG device.
排除标准
- •Known contraindication or allergy to NOACs or aspirin, preventing use of the drugs post-procedure
- •Required to take P2Y12 platelet inhibitor after the study procedure (e.g., due to percutaneous coronary intervention)
- •Patients with heart prosthetic valves
- •Patient implanted with an inferior vena cava filter
- •Patients with left ventricular ejection fraction ≤30%
- •Patients with NYHA Class IV heart failure
- •Patients who have undergone any invasive intervention or surgery within 30 days prior to the index procedure (diagnostic catheterization is not within scope, however, percutaneous coronary intervention is within scope)
- •Patients who have experienced stroke or transient ischemic attack within 90 days prior to study procedure
- •Patients who have had previous attempt at LAA surgical or epicardial intervention (e.g., stapling, suturing, ligation, epicardial LAA management device)
- •Patients previously diagnosed long-standing persistent atrial fibrillation (Continuous AF greater than 1 year in duration)
- •Patients with arrhythmia due to reversible causes including thyroid disorders, acute alcohol intoxication, electrolyte imbalance, severe untreated sleep apnea, and other major surgical procedures within 90 days prior to the study procedure
- •Patients unable to receive heparin or an acceptable alternative to achieve adequate intra-procedural anticoagulation
- •Patients with a stent, constriction, or stenosis in a pulmonary vein
- •Patients with severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2)
- •Patients with severe renal failure (estimated glomerular filtration rate <30 ml/min/1.73m2) or on chronic dialysis
- •Patients with severe pulmonary disease (e.g., 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
- •Patients with hypertrophic cardiomyopathy (maximal LV wall thickness ≥ 15 mm in the absence of abnormal loading conditions such as hypertension or aortic stenosis)
研究组 & 干预措施
Treatment
Experimental
Concomitant procedure utilizing the Volt PFA System and Amulet 2 device in patients indicated for both AF ablation and percutaneous LAAO implant.
干预措施: PVI Ablation (Procedure)
Treatment
Experimental
Concomitant procedure utilizing the Volt PFA System and Amulet 2 device in patients indicated for both AF ablation and percutaneous LAAO implant.
干预措施: Left Atrial Appendage Occluder Implant (Device)
研究者
研究点 (16)
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