Safety and Effectiveness of Pulmonary Vein isOLation And posterioR Wall Ablation wIth pulSed Field Energy in Patients With Paroxysmal and Persistent AF
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 442
- 试验地点
- 8
- 主要终点
- Incidence of early onset primary adverse events (PAEs)
研究概览
简要总结
The primary objective of this clinical investigation is to demonstrate the safety and 12-month effectiveness of pulmonary vein isolation (PVI) and posterior LA wall isolation in the treatment of subjects with symptomatic paroxysmal and persistent atrial fibrillation using the pulsed field ablation with the VARIPULSE™ catheter and the TRUPULSE™ generator.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic paroxysmal and persistent AF with at least one AF episode electrocardiographically documented within 24 months prior to enrollment. Electrocardiographic documentation may include, but is not limited to ECG, Transtelephonic monitoring (TTM), Zio patch monitor, telemetry strip, or consumer devices
- •Age 18-80 years
- •Willing and capable of providing written consent
- •Able and willing to comply with all pre-, post- and follow-up testing and requirements.
排除标准
- •Previous surgical or catheter ablation for AF
- •Documented LA thrombus by imaging within 48 hours before procedure (CT, TEE, or intracardiac echocardiogram at the beginning of the procedure).
- •Uncontrolled heart failure or New York Heart Association (NYHA) Class IV
- •History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran)
- •Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
- •Presence of implanted pacemaker or Implantable Cardioverter-Defibrillator (ICD) or other implanted metal cardiac device that may interfere with the PFA energy field
- •Women who are pregnant (as evidenced by pregnancy test if pre- menopausal), lactating, or who are of child-bearing age and plan on becoming pregnant during the course of the clinical investigation
- •Life expectancy less than 12 months
- •Currently enrolled in an investigational study evaluating another device, biologic, or drug that would interfere with this trial
研究组 & 干预措施
Pulsed Field Ablation
This is a non-randomized one arm study.
干预措施: Pulsed Field Ablation (PFA) (Device)
结局指标
主要结局
Incidence of early onset primary adverse events (PAEs)
时间窗: within seven (7) days of an ablation procedure
Freedom from documented atrial tachyarrhythmia episodes
时间窗: effectiveness evaluation period (Day 91-Day 365)
Freedom from acute procedural failure
时间窗: during ablation procedure
次要结局
未报告次要终点
研究者
Moussa C Mansour
PI
Massachusetts General Hospital