Advisor High Density (HD) Grid Mapping Catheter Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 379
- 试验地点
- 25
- 主要终点
- Rate of Subjects With Acute Success
研究概览
简要总结
The aim of this study is to quantify and characterize the outcomes of radiofrequency (RF) ablation after, and the utility of electroanatomical mapping with the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (hereafter called "HD Grid") and EnSite Precision™ Cardiac Mapping System (SV 2.2 or higher, hereafter called "EnSite Precision") with HD Wave Solution™ voltage mapping (hereafter called "HD Wave Solution") in subjects with persistent atrial fibrillation (PersAF) or ventricular tachycardia (VT) in real-world clinical settings.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Subject must provide written informed consent for study participation and willing and able to comply with the protocol described evaluations and follow up schedule
- •Over 18 years of age
- •Indicated for cardiac electroanatomical mapping and RF ablation procedure to treat PersAF or VT
- •Subject is diagnosed with either PersAF OR VT as defined by:
- •a. Persistent AF: i. Documented symptomatic persistent AF defined as continuous atrial fibrillation that is sustained beyond 7 days but less than 12 months b. VT: i. Sustained monomorphic ventricular tachycardia with record of VT event within last 6 months and history of prior myocardial infarction
排除标准
- •Life expectancy less than 12 months
- •Women who are pregnant or nursing
- •Known intracardiac thrombus or myxoma verified within 48 hours of index ablation procedure
- •Myocardial infarction (MI) or unstable angina, or previous cardiac surgery within 60 days of index ablation procedure
- •Percutaneous coronary intervention (PCI) within 30 days of index ablation procedure
- •Documented cerebro-embolic event within the past 12 months (365 days)
- •History of valve repair, presence of a prosthetic valve, or severe mitral regurgitation thought to require valve replacement or repair within 12 months
- •Awaiting cardiac transplantation or other cardiac surgery within the next 12 months (365 days)
- •Current acute illness or active systemic infection or sepsis
- •Currently enrolled in another clinical study that could confound the results of this study
- •Any cause for contraindication to ablation procedure or systemic anticoagulation
- •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.
- •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
- •Indication-specific exclusion criteria including:
- •a. PersAF: i. PersAF felt to be secondary to electrolyte imbalance, uncontrolled thyroid disease, or reversible or non-cardiac cause.
- •ii. Left atrial diameter (LAD) > 55 mm (parasternal long axis view) iii. Left ventricular ejection fraction (LVEF) < 40% iv. Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV v. Presence of implanted implantable cardioverter-defibrillator (ICD)/implantable cardiac resynchronization therapy defibrillator (CRT-D).
- •b. VT: i. VT/Ventricular Fibrillation (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%
结局指标
主要结局
Rate of Subjects With Acute Success
时间窗: Immediate post procedure
The rate of acute success is defined as the percent of subjects who received HD Grid mapping and RF energy delivery according to label resulting in acute termination of clinical arrhythmia, defined by termination to sinus rhythm (SR) (or AT if being treated for PersAF) or non-inducibility of clinical arrhythmia after ablation (cardioversion allowed prior to inducibility attempt).
Rate of Subjects With Long-term Success
时间窗: PersAF (12 months), VT (6-months)
For PersAF, the rate of long-term success rate is defined as the percent of subjects who receive HD Grid mapping and RF energy delivery according to label and have had freedom from all atrial arrhythmias (AF/AFL/AT) greater than 30 seconds (as documented by 48-hr Holter at 12-month follow-up) and a new or increased dose in class I/III antiarrhythmic drug (AAD). For VT, the percent of subjects who receive HD Grid mapping and RF energy delivery according to label and have had freedom from recurrence of sustained monomorphic VT and a new or increase dose in class I/III AAD at 6-month follow-up. The percent of subjects who are free from the pre-defined endpoints on or off class I/III AADs is also reported.
次要结局
- Mapping Time Associated With Mapping Arrhythmia(During Procedure)
- Number of Mapping Points Collected(During Procedure)
- Radiofrequency (RF) Time(During Procedure)
- Overall Procedure Time(During procedure)
- Fluoroscopy Time(During Procedure)
- Number of Used Mapping Points Per Minute(During Procedure)
- Substrate Characteristics Identified(During Procedure)
- Map Type Used to Define Ablation Strategy(During Procedure)
- Role of HD Wave Solution Configuration Relative to Standard Configuration in Ablation Strategy Decision.(During Procedure)
- Maneuverability of HD Grid Catheter(During Procedure)
- HD Grid Electrogram Quality Relative to Ablation Catheter Electrograms(During Procedure)
- Ablation Strategy(s) Used for PersAF Subjects(During Procedure)
- Ablation Strategy(s) Used for VT Subjects(During the Procedure)