Endocardial Mapping With the CoreMap Electrophysiology Mapping System for Persistent Atrial Fibrillation Protocol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- CoreMap Inc.
- 入组人数
- 245
- 试验地点
- 4
- 主要终点
- Phases 1 and Phase 2 Primary Endpoint:
研究概览
简要总结
This is a global, multi-site, prospective, feasibility study.
详细描述
The INvENI Study consists of three phases:
Phase 1, the goal is to collect and analyze high fidelity endocardial electrograms (EGMs) in patients with persistent AF (PerAF) and long-standing persistent AF and to demonstrate safety.
Phase 2, the goal is the initial development and evaluation of a CoreMap-guided tailored ablation strategy and to demonstrate safety and effectiveness of the CoreMap EP Mapping System in patients with PerAF and long-standing persistent AF.
Phase 3, the goal is to evaluate the safety and effectiveness of the CoreMap EP Mapping System's ability to identify spatially constrained AF drivers and guide ablation therapy in PerAF patients with no history of prior AF ablation. This phase aims to demonstrate safety and effectiveness compared to a control arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Subject has persistent or long-standing persistent AF, at the discretion of the investigator (Phase 1 & 2)
- •Subject has PerAF with no history of prior AF ablation therapy (Phase 3)
- •Subject is 18 to 80 years of age
- •Subject has presence of AF-related symptoms and is scheduled for clinically indicated standard of care AF ablation to manage PerAF (Phase 2 or 3) or long-standing PerAF (Phase 2)
- •Subject is able to provide written informed consent
- •Subject is able and willing to complete all study procedures
排除标准
- •Any of the following within three months of enrollment:
- •Myocardial infarction (MI)
- •Any surgical or percutaneous cardiac procedure including coronary intervention and cardiac ablation
- •Confirmed thrombus on imaging
- •Any of the following within six months of enrollment:
- •Cardiac surgery including coronary artery bypass grafting, ventriculotomy, atriotomy
- •Thromboembolic event (stroke)
- •Any of the following cardiac conditions:
- •New York Heart Association (NYHA) IV
- •Left ventricular ejection fraction (LVEF) < 30%
- •Left atrial diameter >55mm (anterioposterior) (Phase 3)
- •Carotid stenting or endarterectomy
- •Atrial or ventricular septal closure or left atrial appendage closure
- •Implanted permanent pacemaker, biventricular pacemaker, or any type of implantable cardiac defibrillator; loop recorders are permitted.
- •Presence of intramural thrombus, tumor (including atrial myxoma), or other abnormality that precludes vascular access, catheter introduction, or manipulation
- •Unstable angina
- •Prior mitral or tricuspid valve surgery, repair, prosthetic or mechanical valve
- •Moderate to severe mitral valve stenosis or other severe valvular disease
- •Any blood clotting or bleeding abnormalities
- •Contraindication to systemic anticoagulation
- •AF secondary to electrolyte imbalance, acute alcohol intoxication, or reversible or non-cardiac cause
- •Body mass index (BMI) > 40 kg/m2
- •Severe pulmonary disease, pulmonary hypertension, or any chronic respiratory condition
- •Renal failure requiring dialysis or transplant
- •Acute illness, active systemic infection, or sepsis
- •Active drug or alcohol dependency
- •Hypertrophic cardiomyopathy or cardiac amyloidosis
- •Cor pulmonale
- •Any contra-indication that may extend procedure time, at the discretion of the operator
- •Any woman known to be pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence
- •Subject considered part of vulnerable population
- •Life expectancy less than one year
- •Employee of the study site or Sponsor
- •Subjects who are currently enrolled in another study that would directly interfere with this study
研究组 & 干预措施
Phase 2- Map Guided Ablation
The Phase 2 goal is the initial development and evaluation of a CoreMap-guided tailored ablation strategy and to demonstrate safety and effectiveness of the CoreMap EP Mapping System in patients with PerAF and long-standing persistent AF..
干预措施: CoreMap EP Mapping System Mapping (Device)
Phase 3 - Map Guided Ablation
For Phase 3, the goal is to evaluate the safety and effectiveness of the CoreMap EP Mapping System's ability to identify spatially constrained AF drivers and guide ablation therapy in PerAF patients with no history of prior AF ablation therapy. This phase aims to demonstrate safety and effectiveness compared to a control arm.
干预措施: CoreMap EP Mapping System Mapping (Device)
Phase 1- Mapping Only
For Phase 1, the goal is to collect and analyze high fidelity endocardial electrograms (EGMs) in patients with persistent AF (PerAF) and long-standing persistent AF and to demonstrate safety.
干预措施: CoreMap EP Mapping System Mapping (Device)
Phase 2- Map Guided Ablation
The Phase 2 goal is the initial development and evaluation of a CoreMap-guided tailored ablation strategy and to demonstrate safety and effectiveness of the CoreMap EP Mapping System in patients with PerAF and long-standing persistent AF..
干预措施: CoreMap EP Mapping System Map-Guided Ablation (Device)
Phase 3 - Map Guided Ablation
For Phase 3, the goal is to evaluate the safety and effectiveness of the CoreMap EP Mapping System's ability to identify spatially constrained AF drivers and guide ablation therapy in PerAF patients with no history of prior AF ablation therapy. This phase aims to demonstrate safety and effectiveness compared to a control arm.
干预措施: CoreMap EP Mapping System Map-Guided Ablation (Device)
结局指标
主要结局
Phases 1 and Phase 2 Primary Endpoint:
时间窗: 7 days
Incidence of study device related serious adverse events within seven (7) days of the study procedure.
Phase 2 and Phase 3 Primary Effectiveness Endpoint:
时间窗: 6 and 12 months
Freedom from documented recurrence of AF, atrial tachycardia (AT), or atrial flutter (AFL) based on electrocardiographic data through a 12-month follow-up and excluding a 90-day blanking period.
次要结局
- Phase 1 Secondary Endpoint:(perioperatively/periprocedurally)
- Phase 2 Secondary Endpoints:(perioperatively/periprocedurally)
- Phase 3 Secondary Endpoints:(perioperatively/periprocedurally)