Influence of an Innovative Telemetric Smartphone Application on Re-hospitalization And Quality of Life After Cryoballoon Pulmonary vEin Isolation in Patients With Paroxysmal Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Rehospitalization Recurrence of AF
研究概览
简要总结
A randomized, open, mono-centric pilot study to investigate the influence of an innovative telemetric smartphone application on re-hospitalization and quality of life after cryoballoon pulmonary vein isolation in patients with paroxysmal atrial fibrillation.
详细描述
The telemetric smartphone application includes a digitized medical record, a mobile ECG device and a 24-hour on call service by a cardiologist. The hypothesis is that the use of a telemetric smartphone application can reduce re-hospitalization in patients after cryoballoon pulmonary vein isolation. Secondary endpoints are quality of life measurements, health care cost calculations and recurrences of atrial fibrillation after ablation. All patients will undergo ablation and will be randomized into two groups: 1) conventional follow up with outpatient visits 6 and 12 months after ablation compared to 2) a structured follow up with the smartphone application, a mobile ECG device (patients will be able to send in as many ECGs as wanted), up to three phone calls with a cardiologist (24-hour on call service) as well as outpatient visits 6 and 12 months after cryo-ablation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
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
- •Age > 18 years
- •Written informed consent
- •symptomatic paroxysmal atrial fibrillation (at least two episodes within 3 months prior to ablation)
- •cryoballoon pulmonary vein isolation
- •possession of a compatible smartphone
排除标准
- •Age < 18 years
- •persistent or permanent atrial fibrillation (AF)
- •prior catheter or surgical ablation of AF
- •pregnant females
- •contraindication for oral anticoagulation
- •manifest hyper-/hypothyroidism
- •no intention to cooperate
- •alcoholism
研究组 & 干预措施
Conventional follow up
Conventional follow up at physician practice
干预措施: Conventional follow up (Other)
Telemetric smartphone application
Structured follow up with a telemetric smartphone application
干预措施: Telemetric smartphone application (Device)
结局指标
主要结局
Rehospitalization Recurrence of AF
时间窗: in 12 months follow up
Rate of rehospitalization after cryoballoon pulmonary vein isolation in patients with paroxysmal atrial fibrillation, Recurrence of sustained atrial fibrillation (\>30 seconds) after atrial fibrillation ablation
次要结局
未报告次要终点