Precision Ablation For Pulmonary Vein Isolation: Targeting Pulmonary Vein Myocardial Sleeves With Omnipolar Mapping Technology - A Randomized Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of minutes taken from Initial puncture to transseptal access
研究概览
简要总结
The purpose of this study is to compare procedural times and Radiofrequency (RF)applications required for Pulmonary vein myocardial sleeves targeted pulmonary vein ablation (PVS-PVI) , to compare the efficacy of PVS-PVI , to compare the safety of PVS-PVI and to assess other clinical outcomes of PVS-PVI in individuals with symptomatic paroxysmal Atrial fibrillation (AF) using Omnipolar Technology with conventional Wide area circumferential ablation (WACA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Symptomatic paroxysmal AF refractory to at least one Class I or Class III antiarrhythmic medication, intolerance to antiarrhythmic medications, or a preference to not trial antiarrhythmic medications
- •A minimum of one documented AF episode via 12-lead ECG, Holter monitor, or loop recorder
- •Capability to provide informed consent
排除标准
- •Persistent or permanent AF
- •Prior history of catheter or surgical ablation for AF or left atrial ablation for atypical flutter
- •Reversible causes of AF
- •Congenital heart disease
- •Significant valve disease (moderate or severe mitral/aortic stenosis or regurgitation)
- •Pregnancy
- •Known presence of intracardiac thrombus
- •Systemic oral anticoagulation therapy contraindicated, including a history of heparin-induced thrombocytopenia
- •Broad vortex-like connections and no clear PVMS to be targeted
研究组 & 干预措施
PVS-PVI
干预措施: PVS-PVI targeted ablation (Device)
WACA
干预措施: Wide area circumferential ablation (WACA) (Device)
结局指标
主要结局
Number of minutes taken from Initial puncture to transseptal access
时间窗: From time of Initial puncture to time of transseptal access (an average of 10 minutes)
Number of minutes taken from transseptal access to left atrium 3D map completion
时间窗: From time of transseptal access to time of left atrium 3D map completion (an average of 15 minutes)
Number of minutes taken from left atrium 3D map completion to when all pulmonary veins are isolated
时间窗: From time of left atrium 3D map completion to time when all pulmonary veins are isolated (an average of 30-60 minutes)
Number of minutes with catheters in the left atrium
时间窗: from time catheters are inserted to time catheters are removed (an average of 45-80 minutes)
Time from initial puncture till all sheaths removed
时间窗: From time of initial puncture to time when all sheaths removed (an average of 90 minutes)
Total time of radiofrequency applications in seconds
时间窗: from start of radiofrequency application to end of radiofrequency applications(an average of 300-900 seconds)
Number of radiofrequency applications used
时间窗: end of procedure (an average of 1.5 hours after baseline)
次要结局
- Day and time to first recurrence of any documented atrial arrhythmias(an average of 91 days after catheter ablation)
- Time in sinus rhythm as assessed by the percentage of time that the patient remains in sinus rhythm during the pre-established monitoring(6 months follow up)
- Number of Procedure-related complications(end of study (6 months after procedure))
- Number of deaths(end of study (6 months after procedure))
- Total radiation exposure dose(end of procedure (about 1.5 hours after start of procedure))
- Number of participants that need a repeat catheter ablation procedure due to documented recurrence of symptomatic atrial arrhythmia(end of procedure till 6 months after procedure)
- Number of occurrences of any AF (symptomatic or asymptomatic) documented on ECG or ILR(during the first 90 days following catheter ablation.)
- Number of participants that visit the emergency room(end of procedure till 6 months after procedure)
- Number of participants that are hospitalized(end of procedure till 6 months after procedure)
- Number of incidences of stroke(end of procedure till 6 months after procedure)
- Change in quality of life as assessed by the Quality of Life (EQ-5D-5L) assessment(Baseline, 6 months after procedure)
- Number of participants that show a need for electrical cardioversion(end of procedure till 6 months after procedure)
- Time in sinus rhythm as assessed by the percentage of time that the patient remains in sinus rhythm during the pre-established monitoring(3 months follow up)
研究者
Ramesh Hariharan
Professor
The University of Texas Health Science Center, Houston