NL-OMON48299已完成不适用
Advisor HD Grid Observational Study - Advisor HD Grid Observational Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Subject must provide written informed consent for study participation and willing and able to comply with the protocol described evaluations and follow up schedule.
- •2. Over 18 years of age
- •3. Indicated for cardiac electroanatomical mapping and RF ablation procedure to treat PersAF or VT
- •4. Subject is diagnosed with either PersAF OR VT as defined by:
- •a. Persistent AF <= Documented symptomatic persistent AF defined as continuous atrial fibrillation that is sustained beyond 7 days but less than 12 months
- •b. VT <= Sustained monomorphic ventricular tachycardia with record of VT event within last 6 months and history of prior myocardial infarction
排除标准
- •1. Life expectancy less than 12 months
- •2. Women who are pregnant or nursing
- •3. Known intracardiac thrombus or myxoma verified within 48 hours of index ablation procedure
- •4. Myocardial infarction (MI) or unstable angina, or previous cardiac surgery within 60 days of index ablation procedure
- •5. Percutaneous coronary intervention (PCI) within 30 days of index ablation procedure
- •6. Documented cerebroembolic event within the past 12 months (365 days)
- •7. History of valve repair, presence of a prosthetic valve, or severe mitral regurgitation thought to require valve replacement or repair within 12 months
- •8. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months (365 days)
- •9. Current acute illness or active systemic infection or sepsis
- •10. Currently enrolled in another clinical study that could confound the results of this study
- •11. Any cause for contraindication to ablation procedure or systemic anticoagulation
- •12. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator*s opinion, could limit the subject*s ability to participate in the clinical study or to comply with follow-up requirements, or impact the scientific soundness of the clinical study results.
- •13. Vulnerable patient or individuals whose willingness to volunteer in a study, in the judgement of investigator or public authorities, could be unduly influenced by lack of or loss of autonomy
- •14. Indication-specific exclusion criteria including:
- •i. PersAF felt to be secondary to electrolyte imbalance, uncontrolled thyroid disease, or reversible or non-cardiac cause.
- •ii. Prior catheter ablation for AF beyond pulmonary vein isolation
- •iii. LAD > 55 mm (parasternal long axis view)
- •iv. LVEF < 40%
- •v. Uncontrolled heart failure or NYHA function class III or IV
- •vi. Presence of implanted ICD/CRT-D
- •i. VT/VF thought to be from channelopathies
- •ii. Active ischemia or other reversible cause of VT
- •iii. Incessant VT at time of procedure
- •iv. Implanted with a ventricular assist device (VAD) (e.g. TandemHeart)
- •v. Chronic NYHA Class IV heart failure
- •vi.Ejection fraction < 15%
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