Vdrive Evaluation of Remote Steering and Testing in Lasso Electrophysiology Procedures Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Stereotaxis
- 入组人数
- 120
- 试验地点
- 10
- 主要终点
- Safety Outcome to be Assessed by Comparing the Rate of Adjudicated Serious Adverse Events Within 7 Days of the Procedure Between Both the Control and the Investigational Device Groups.
研究概览
简要总结
This study will evaluate the use of a robotic device that is remotely controlled to maneuver a circular mapping catheter in the left atrium during Atrial Fibrillation (AF) ablation procedures.
详细描述
Key to the success of an electrophysiology procedure is the ability to accurately map, sense and pace the heart. Electrophysiology mapping catheters are available in a variety of shapes and electrode configurations. The majority of these catheters are manipulated manually by the physician. The Vdrive simplifies these manipulations by allowing an operator to mechanically advance, retract, rotate, deflect and maneuver a circular mapping catheter. The circular mapping catheter is not altered in structure, function or indication in the same manner as the predicate device (Cardiodrive Catheter Advancement System).
This is a prospective, randomized, non-blinded, controlled study comparing manual navigation of a circular mapping catheter with mechanical navigation by the Vdrive. A total of 120 patients are expected to complete the study: 80 patients in the Vdrive navigation arm and 40 patients in the manual navigation arm. Patients will be enrolled at a minimum of one site in the European Union where the product is currently marketed and the United States, where the Vdrive is considered to be investigational.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Left atrial AF ablation procedure requiring the use of a Lasso mapping catheter
- •Subject must be at least 18 years of age
- •Subject must be male, female of no childbearing potential, or a female that has a negative pregnancy test prior to randomization
排除标准
- •Unable to safely expose subject to a magnetic field
- •Prior AF ablation procedure
- •Patients with fewer than 4 PVs are excluded
- •Patients with persistent AF in whom early recurrence of AF following cardioversion would preclude completion of the pacing maneuvers described in the protocol or patients with other conditions that would similarly preclude completion of the pacing maneuvers
- •Contraindication to procedure or unable to return for follow-up
- •History of clotting disorder, bleeding abnormalities or contraindication to anticoagulation
- •Actively participating in other cardiac device trial(s)
- •Currently pregnant
- •Under 18 years of age
- •Prosthetic valves
- •Atrial abnormalities (thrombus, myxoma or baffle)
- •Other exclusions per the investigator
结局指标
主要结局
Safety Outcome to be Assessed by Comparing the Rate of Adjudicated Serious Adverse Events Within 7 Days of the Procedure Between Both the Control and the Investigational Device Groups.
时间窗: 7 days Follow-up
The Vdrive will allow physicians to manipulate compatible circular mapping catheters while maintaining a safety profile that is not inferior to manual circular catheter navigation. The one-sided null hypothesis was to be tested at the α = 0.05 significance level using a standard unpooled asymptotically normal test statistic. The null hypothesis was to be rejected if Z \< -1.7046 or, equivalently, if the corresponding p-value was less than 0.05.
The Primary Effectiveness Endpoint is the Successful Navigation and EGM Recording of Each Pre-specified Pulmonary Vein Per Procedure Between Both the Control and the Investigational Device Groups.
时间窗: Peri-procedural
Success was navigating and sensing by obtaining an EGM at the pre-specified targeted PVs. The null hypothesis was to be tested at the α = 0.05 significance level using a test statistic Z based on the Farrington and Manning likelihood score statistic with adjustment to take into account the correlation between multiple observations (PVs) on the same subject. The null hypothesis was to be rejected if Z \> 1.645 or, equivalently, if the corresponding p-value was less than 0.05.
次要结局
未报告次要终点