NCT05839873进行中（未招募）不适用
Abbott Ventricular Tachycardia Post Approval Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 62
- 试验地点
- 11
- 主要终点
- Rate of study device- and/or Study Ablation Procedure-related SAEs through 12 months post Index Ablation Procedure.
研究概览
简要总结
This post-approval study (PAS) is designed to provide continued clinical evidence to confirm the long-term safety and effectiveness of the FlexAbilityTM Ablation Catheter, Sensor EnabledTM (FlexAbility SE) for the treatment of ventricular tachycardia in a post-market environment. This is a prospective, single arm, open-label, multi-center, observational study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 7 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient or legally acceptable representative or parent/guardian (as applicable) must provide written informed consent prior to any clinical investigation-related procedure
- •Subjects who have recurrent, drug-refractory, sustained MMVT with non-ischemic structural heart disease and a clinical decision has been made to use FlexAbility SE for an ablation procedure prior to enrollment in the research study
- •Refractory (i.e. not effective, not tolerated or not desired) to at least one Class I/III anti-arrhythmic medication for treatment of MMVT
- •Implanted with a market released ICD or CRT-D prior to the Index Ablation Procedure
- •Able and willing to comply with all study requirements
排除标准
- •Documented or known intracardiac thrombus or myxoma
- •Active systemic infection
- •History of atriotomy or ventriculotomy within 4 weeks prior to the Index Ablation Procedure
- •Patients with prosthetic valves as the catheter may damage the prosthesis
- •Unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation
结局指标
主要结局
Rate of study device- and/or Study Ablation Procedure-related SAEs through 12 months post Index Ablation Procedure.
时间窗: 12 Month
Composite of 12-month freedom from VT recurrence, death, and cardiac transplantation
时间窗: 12 Month
次要结局
未报告次要终点
研究者
研究点 (11)
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