Radiofrequency Ablation of Atrial Fibrillation Under Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 10
- 主要终点
- Catheter Stability Metrics as measured by maximum and minimum contact force.
研究概览
简要总结
This study seeks to assess the effect of apnea (breath hold) during atrial fibrillation (AF) ablation by having all ablations performed under apnea. By prospectively studying the effects of apnea on AF ablation, the investigators wish to demonstrate its feasibility, safety and impact on patient outcomes. This is a prospective study that includes both an apnea arm and a control arm. The subjects who consent to the apnea arm will undergo an atrial fibrillation ablation with periods of apnea. The subjects who consent to the control arm will agree to have their data from their standard of care atrial fibrillation be collected for comparison.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 80 years old.
- •Symptomatic paroxysmal atrial fibrillation.
排除标准
- •Patients with persistent or permanent atrial fibrillation or prior atrial fibrillation ablation.
- •Significant chronic obstructive pulmonary disease (such as those requiring home oxygen).
- •Severe pulmonary hypertension.
- •Other intrinsic lung pathology such as interstitial lung disease.
- •Severe systolic dysfunction defined as left ventricular ejection fraction < 30%.
结局指标
主要结局
Catheter Stability Metrics as measured by maximum and minimum contact force.
时间窗: Day 1
Maximum contact force: range between 0 and 60 grams
Catheter Stability Metrics as measured by time to impedance drop.
时间窗: Day 1
Time to 5 ohm and 10 ohm impedance drop: range 1 to 60 seconds
Efficacy as measured by percentage of veins isolated after first pass.
时间窗: Day 1
Percentage of veins isolated after first pass: 0-100%
Catheter Stability Metrics as measured by contact force variability.
时间窗: Day 1
Contact force variability: Catheter stability metrics will be calculated as standard deviations of contact forces measured during the course of reach ablation region. Contact forces and their standard deviations will range between 0 and 60 grams.
Catheter Stability Metrics as measured by average contact force.
时间窗: Day 1
Average contact force: range between 0 and 60 grams
Catheter Stability Metrics as measured by catheter displacement.
时间窗: Day 1
Catheter displacement (mean): range 0-10 mm
Efficacy as measured by time to pulmonary vein isolation.
时间窗: Day 1
Time to pulmonary vein isolation (minutes): expected range 60 - 180 minutes
次要结局
- Clinical Outcomes as measured by recurrence of atrial fibrillation at six months post procedure.(month six)
- Procedural time as measured by the length of time from start to end of procedure.(Day 1)
- Clinical Outcomes as measured by recurrence of atrial fibrillation at 12 months post procedure.(month 12)
- Safety, as measured by number of subjects with at least one adverse event.(End of study (12 months))