Multi-center Comparative Effectiveness Randomized Trial to Assess a Transseptal Approach to Left Ventricular Ablation Compared to Retrograde to Prevent Cerebral Emboli & Neurocognitive Decline in Adults With Ventricular Tachycardia/Premature Ventricular Contractions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 41
- 主要终点
- overall neurocognitive function, change
研究概览
简要总结
This study is a prospective, multicenter, randomized (1:1) controlled comparative effectiveness trial of a transseptal approach to left ventricular ablation compared to a retrograde aortic approach to prevent cerebral emboli and neurocognitive decline in adults with ventricular tachycardia (VT) and/or premature ventricular contractions (PVCs).
详细描述
This study is a prospective, multicenter, randomized (1:1) controlled comparative effectiveness trial of a transseptal approach to left ventricular ablation compared to a retrograde aortic approach to prevent cerebral emboli and neurocognitive decline in adults with ventricular tachycardia (VT) and/or premature ventricular contractions (PVCs). Participants will be followed for 6 months post-study procedure. This study will be conducted at up to 12 clinical sites in the United States. A total of one-hundred and fifty (150) participants will be enrolled and randomized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women ≥ 18 years of age
- •Planned/scheduled endocardial ventricular tachycardia (VT) or premature ventricular contraction (PVC) catheter ablation procedure
- •For this patient, the current plan of the operator must be to pursue a catheter ablation target in the left ventricular endocardium that can be accessed by either a transseptal puncture or retrograde aortic approach
- •Life expectancy of at least 1 year
- •Willing and able to undergo pre- and post-ablation MRIs
- •Willing and able to return and comply with scheduled follow up visits (through the 6 month follow-up)
- •Willing and able to provide written informed consent
排除标准
- •Planned epicardial ablation that would include a coronary angiogram (during the index ventricular tachycardia (VT) or premature ventricular contraction (PVC) catheter ablation procedure)
- •Any contraindication to MRI (as defined by the institution performing the MRI)
- •Clinical contraindication to a retrograde aortic approach as determined by the treating physician, including:
- •Severe aortic stenosis
- •Mechanical aortic valve
- •Clinical contraindication to a transseptal puncture as determined by the treating physician, including:
- •Severe Mitral valve stenosis
- •Mechanical Mitral valve
- •Atrial septal defect (ASD) or Patent foramen ovale (PFO) closure device that would preclude a transseptal puncture
- •Mitraclip or Alfieri mitral valve repair that would preclude a transseptal puncture
- •Planned or known need to perform either a retrograde aortic approach or transseptal approach (such as to target another site during the same procedure)
- •Inability to speak, read, and write in the English language at a 6th grade level (required for the Neurocognitive Function Testing)
- •Current mental impairment or other diagnosis which precludes accurate assessment of neurocognitive function or which may not allow patient to understand the nature, significance and scope of the study
- •Inability to perform neurocognitive function testing after > 24 hours free of sedating medications
结局指标
主要结局
overall neurocognitive function, change
时间窗: from baseline (pre-ablation) to 6 months post-ablation
percent change in overall neurocognitive function score from baseline (pre-ablation). The neurocognitive function examination includes items from the Brain Health Assessment, a validated, multi-domain testing battery aims to detect cognitive impairment in older adults. The TRAVERSE Testing Battery will include the following tests: Favorites (Forms A and B), Match (Forms A and B), Favorites Delay (Forms A and B), Favorites Recognition (Forms A and B), Dot Counting (Forms A and B), Flanker, and Running Dots.
cerebral embolic lesion incidence
时间窗: on day 1 post-ablation
incidence of new cerebral embolic lesions measured by magnetic resonance imaging (MRI) post-ablation as compared to pre-ablation imaging studies
次要结局
- quality of life composite score, change(from baseline (pre-ablation) to 6 months post-ablation)
- complications related to the ablation procedure, rate(post-ablation, through Month 6)
- symptoms specific to VT/PVC, change(from pre-ablation to post-ablation, through Month 6)
- physical activity (MET-min/week), change(from baseline (pre-ablation) to 6 months post-ablation)
- recurrent arrhythmias, rate(at 6 months post-ablation)
- new cerebral embolic lesions, number(on day 1 post-ablation)