NCT03906461已完成不适用
LSI (Lesion Index) Workflow Post-Market Observational Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 9
- 主要终点
- Mean Achieved Lesion Index (LSI) Values
研究概览
简要总结
This clinical study is a prospective, multicenter, post-market, single-arm, observational study designed to characterize the usage of the Lesion Index (LSI) with the market-released TactiCath Contact Force Ablation Catheter, Sensor Enabled (TactiCath SE) in subjects with Paroxysmal Atrial Fibrillation (PAF) in a real-word environment.
详细描述
The primary objective of this study is to characterize LSI achieved values for durable lesion formation using the TactiCath SE catheter in the different anatomical regions around the pulmonary veins (PVs) of the heart during RF ablation for the treatment of drug-refractory paroxysmal atrial fibrillation (PAF)
Secondary objectives of this study are as follows:
- To characterize the use of EnSite Automap and AutoMark module software settings, including LSI threshold (OUS), contact force, time, power, flow, and AutoMark spacing using the TactiCath SE catheter for RF ablation for the treatment of drug-refractory PAF.
- To characterize LSI achieved values for lesions that reconnected versus those that were durable, both in an acute procedural setting as well as in patients who undergo additional ablations during the 12-month follow-up period after an index RF ablation procedure for the treatment of drug-refractory PAF.
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
- 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 prior to any clinical investigation related procedure.
- •Subject is at least 18 years of age.
- •Subject is willing and able to comply with the protocol-described evaluations and follow-up schedule.
- •Subject plans to undergo a pulmonary vein isolation (PVI) procedure due to symptomatic paroxysmal AF using RF ablation.
- •Subject is refractory or intolerant to at least one class I or class III anti-arrhythmic drug.
- •For the purposes of this study, "intolerant" includes either:
- •Subject attempted the drug at any dose and either the subject or their physician chose to discontinue for any reason.
- •Subject was offered the drug and refused to take for any reason.
排除标准
- •Previous ablation or surgery in the left atria.
- •Has an implantable cardiac defibrillator (ICD) (pacemakers without defibrillation capacity are allowable).
- •Participation in another clinical investigation that may confound the results of this study.
- •Pregnant or nursing.
- •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 investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
- •Life expectancy less than 12 months.
结局指标
主要结局
Mean Achieved Lesion Index (LSI) Values
时间窗: At time of procedure
The primary endpoint is a summary of Lesion Index (LSI) values achieved for radiofrequency ablation catheter lesion formation in different anatomical regions of the heart around the pulmonary veins (PVs). LSI is a proprietary index that combines contact force, radiofrequency duration, and radiofrequency current into a single value to express the gradual growth of lesion formation with increasing LSI values.
次要结局
- Ensite AutoMark Settings and Characteristics: Average RF Power Delivered(At time of procedure)
- Ensite AutoMark Settings and Characteristics: Contact Force(At time of procedure)
- Ensite AutoMark Settings and Characteristics: Time and AutoMark Time Parameters(At time of procedure)
- Ensite AutoMark Settings and Characteristics: AutoMark Lesion Spacing Parameter(At time of procedure)
- Number of Participants With Acute Electrical Isolation of Pulmonary Veins(20 minutes after last RF ablation in PV region)
- Number of Participants With 7-Day Device or Procedure Related SAEs(within 7-days of index procedure)
- Number of Participants With Freedom From AF/AFL/AT Recurrence(No documented episodes greater than 30 seconds with a 24hour-Holter)
- Number of Participants That Required Touch up Ablation in Each Region(At time of procedure)
- Number of Participants With 12-Month Device or Procedure Related SAEs(between 7 days and 12-months of index procedure)
- Quality of Life Changes 12-Month(12-months post index ablation, compared to baseline scores)
- Number of Participants With Repeat Ablation(12-months post index procedure (excluding 90-day blanking period))
- Overall Procedure Time(At time of procedure)
- Overall Fluoroscopy Time(At time of procedure)
- Quality of Life Changes 6-Month(6 months post index ablation, compared to baseline scores)
- Number of Participants in Which Pulmonary Veins Required Touch-up Ablation(At time of procedure)
- Number of Participants That Required Index Procedure Touch-up Ablations(At time of procedure)
- LSI Achieved Values for Repeat RF Ablations(up to 12-months post index procedure, characterization of LSI achieved values for lesions that resulted in electrically conducting gaps versus those that were durable)
- Overall RF Ablation Time(At time of procedure)
- Number of Participants on Antiarrhythmic Drugs(12-months)
- Number of Participants With Health Care Utilization(collected throughout the 12-month follow-up period)
研究者
研究点 (9)
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