TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter
研究概览
简要总结
The TOCCASTAR Study will assess the safety and effectiveness of a contact force sensing catheter used for ablation in patients with paroxysmal atrial fibrillation. Subjects will be randomized for treatment with either the TactiCath catheter or another ablation catheter with no contact force sensing capability. Patients will be followed for 12 months to compare the incidence of serious adverse events and freedom from recurring, symptomatic AF between the two study arms. Additional measures of treatment success including quality of life, recurrence of asymptomatic AF and procedural efficiency will also be studied.
A second phase of the study will treat up to 50 non-randomized subjects with a new version of the device under the same protocol.
详细描述
It has been hypothesized that the ability to create durable lesions during radiofrequency (RF) ablation is directly correlated with a reduction in the recurrence of arrhythmia in patients with paroxysmal atrial fibrillation (PAF). Lesion depth is directly correlated with the contact force measured between the the tip of the catheter and the heart tissue. In this study, patients in whom a pulmonary vein isolation procedure has been prescribed for the treatment of PAF will be randomized for treatment with either a device incorporating contact force sensing or one without.
To be included in the study, patients 18 or older must demonstrate a history of atrial fibrillation and will have failed treatment using antiarrhythmic medications. In both study arms, ablation will be performed using an accepted treatment strategy and standard procedures. Patients will receive routine follow-up for 12 months after the procedure, with the addition of ambulatory monitoring to detect the recurrence of episodes of atrial arrhythmia. The study will compare the effectiveness of the procedure in the two arms, and will characterize any differences in safety outcomes primarily related to complications arising from the use of an ablation device and the ablation procedure.
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
- Single (Participant)
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
- •symptomatic PAF refractory to at least one Class I-IV antiarrhythmic drug
- •minimum one documented PAF episode >30 sec duration within prior 12 months
- •minimum three PAF episodes during prior 12 months
- •18 years or older
排除标准
- •persistent or long-standing persistent AF
- •four or more cardioversions in prior 12 months
- •MI, CABG or PCI within preceding 3 months
- •left atrial diameter > 5.0 cm
- •LVEF < 35%
- •NYHA class III or IV
- •previous left atrial ablation procedure
- •previous tricuspid or mitral valve repair surgery
研究组 & 干预措施
TactiCath
Catheter ablation to treat paroxysmal AF using the TactiCath catheter with contact force capability
干预措施: Catheter ablation to treat paroxysmal atrial fibrillation (Device)
Control
Catheter ablation to treat paroxysmal AF using a catheter with no contact force sensing capability
干预措施: Catheter ablation to treat paroxysmal atrial fibrillation (Device)
结局指标
主要结局
Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter
时间窗: 12 months
Includes both acute success (successful electrical isolation of all pulmonary veins) and chronic success. Re-treatment for AF with ablation or the use of Class I or Class III antiarrhythmic drugs after a 3 month blanking period constitute a treatment failure.
Incidence of Device-related Early-onset Primary Serious Adverse Events
时间窗: 12 months
Includes serious adverse events occurring within 7 days of the index procedure or hospital discharge, whichever is later, and diagnosed at any time during the follow-up period.
次要结局
未报告次要终点