Versatility of a Circular Multielectrode Catheter in the Individualized Recognition & Treatment of Atrial Fibrillation and Related Arrhythmias Using Pulsed Field Energy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 141
- 试验地点
- 1
- 主要终点
- Number of participants with acute procedural success
研究概览
简要总结
The purpose of this pragmatic study is to evaluate the safety, performance and effectiveness of the VARIPULSE catheter technology used in combination with the TRUPULSE™ Generator, and the compatible EAM system (Carto 3D) to treat patients with atrial fibrillation and related arrhythmias during clinically-indicated ablation procedures.
详细描述
By virtue of its efficiency, safety profile, and potential for improved efficacy in certain patient populations (e.g., thickened atrial tissue of hypertrophic cardiomyopathy (HCM) patients), there is tremendous excitement about the role of pulsed field ablation (PFA) to treat atrial fibrillation and related arrhythmias. However, most PFA clinical trials enroll very selected populations and have highly focused inclusion/exclusion criteria - for example, typically only paroxysmal or persistent atrial fibrillation (AF) patients with upper age criteria are included, other disease states such as HCM are excluded, and typically redo ablation procedures are also excluded. The latter is particularly problematic since redo procedures are quite prevalent in most physicians' clinical practice.
In some sense, the incorporation of these restrictive criteria is not terribly surprising since most of the novel PFA catheters are specifically designed to perform only certain aspects of the AF ablation procedure (e.g., just PVI). That is, when there are more complex substrates (where other types of lesion sets may be needed), it may not be practical to allow a more inclusive criteria for enrollment. Of course, the downside is that the majority of the patients that are eventually treated in clinical practice are not reflected by the enrolled patient population.
The VARIPULSE™ catheter technology is a novel circular catheter with a variable loop design, containing multiple electrodes with individual irrigation pores capable of delivering pulse-field energy.
The Ablation procedure will follow the below sequence:
- Anatomical and voltage mapping of the left and/or right atrium
- To perform this mapping, the VARIPULSE bi-directional catheter or a compatible conventional FDA-approved multi-electrode mapping catheter (e.g., Pentaray, Octaray or Optrell) may be used
- Activation mapping of any-presenting or inducible atrial flutter
- Pulmonary Vein Isolation (PVI) to be achieved in all patients with atrial fibrillation (if not already achieved).
- Confirmation of entrance block with adenosine or isoproterenol challenge
- Additional ablation lesion sets are per the investigator's discretion including:
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
- •Age 18 or older.
- •Diagnosed with atrial fibrillation or atrial atypical atrial flutter (typical flutter may also be ablated provided that the typical flutter occurs in addition to atrial fibrillation or atypical flutter; that is, typical flutter as the sole arrhythmia should not undergo PFA).
- •Previous surgical or catheter ablation for atrial fibrillation is allowed
- •Planned for a catheter ablation procedure
- •Able and willing to provide written consent and comply with all testing and follow-up requirements
- •Have in place or are planned to receive an implantable loop recorder, pacemaker or defibrillator capable of recording atrial rhythm
排除标准
- •Documented "active" left atrial thrombus
- •Conditions that preclude the introduction and manipulation of intracardiac catheters: eg, active intracardiac thrombus, myxoma, tumor, a prohibitive interatrial baffle or patch, etc.)
- •Previous PCI/MI within the past 1 month
- •Active systemic infection or sepsis
- •Uncontrolled heart failure - New York Heart Association (NYHA) function class IV.
- •History of blood clotting, bleeding abnormalities or contraindication to anticoagulation.
- •Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment.
- •Women who are pregnant, lactating, or who are of childbearing age and plan on becoming pregnant during this trial.
- •Life expectancy or other disease processes likely to limit survival to less than 12 months.
- •Currently enrolled in an investigational study evaluating another device, biologic, or drug, that would interfere with this trial.
结局指标
主要结局
Number of participants with acute procedural success
时间窗: up to 12 months post-procedure
Acute procedural success is defined according to the type of arrhythmia, for example: * Entrance block in all targeted PVs for patients treated for atrial fibrillation (Both first and Re-Do) * Termination of atrial flutters for patients presenting in atrial flutter.
次要结局
- Percentage of patients taking anti-arrhythmic medications with no evidence of atrial fibrillation/flutter or tachycardia of more than 30 seconds(after 3-month blanking period until end of 12 months of follow-up)
- Number of patients who experience repeat ablation(up to 12 months post-procedure)
- Percentage of patients who do not report recurrent of symptomatic arrhythmias(after 3-month blanking period until end of 12 months of follow-up)
- Percentage of patients with no evidence of atrial fibrillation/flutter or tachycardia of more than 30 seconds of duration(after 3-month blanking period until end of 12 months of follow-up)
- Percentage of patients presenting with persistent atrial fibrillation with no evidence of atrial fibrillation/flutter or tachycardia of more than 30 seconds(after 3-month blanking period until end of 12 months of follow-up)
- Durability of lesion sets in any patient that undergoes a second procedure(up to 12 months post-procedure)
- Percentage of time spent in atrial flutter/fibrillation/tachycardia(up to 12 months post-procedure)
- Percentage of patients not taking anti-arrhythmic medications with no evidence of atrial fibrillation/flutter or tachycardia of more than 30 seconds of duration(after 3-month blanking period until end of 12 months of follow-up)
- Number of patient Hospitalizations(up to 12 months post-procedure)
- Number of patient emergency room (ER) visits(up to 12 months post-procedure)
- Number of patients requiring cardioversion(up to 12 months post-procedure)
研究者
Vivek Reddy
Professor
Icahn School of Medicine at Mount Sinai