A Prospective Comparison of Quality of Life Following Atrial Fibrillation Ablation Using the Arctic Front Advance Cryo Balloon Compared to Contact Force Sensing Radiofrequency Catheter Ablation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pain Intensity Measurement
研究概览
简要总结
The primary objective is to assess any differences in patient quality of life between Cryo Balloon ablation and Radiofrequency ablation in the treatment of atrial fibrillation. The study will also assess any differences in the amount and duration of pain medication required after the ablation.
详细描述
Currently there are several different accepted techniques for performing ablation of atrial fibrillation. The two primary techniques currently in use in our center for atrial fibrillation are Cryo Balloon and Radiofrequency ablation.
Based on personal observation, it is felt that patients undergoing Radiofrequency ablation have a higher incidence of chest discomfort and subsequently a greater requirement for pain medications post procedure as compared to those patients undergoing Cryo ablation.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Paroxysmal atrial fibrillation who are advised either Cryoablation or Radiofrequency ablation for treatment.
排除标准
- •Persistent atrial fibrillation
- •Taking pain medications for acute or chronic conditions at the time of the procedure.
- •Undergo a combination of Cryoablation and Radiofrequency ablation
- •Radiofrequency group who undergo ablation beyond pulmonary vein isolation
结局指标
主要结局
Pain Intensity Measurement
时间窗: 7 Days
Self report pain intensity measured at baseline and then once a day beginning at least four hours after the ablation. Three individual pain scales will be used. Universal Pain Assessment Tool is scored 0 to 10 with 0 = no pain and 10 = severe.
次要结局
- Health Status and Activity Measurement(7 Days)
- Pain Medication Assessment(30 Days)
研究者
Sumit Verma, MD
Principal Investigator
Langhorne Cardiology Consultants, Inc.