Smartphone Based-PPG Assessment of REconversion in Persistent Atrial Fibrillation: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Cancellation of planned admission for electrical cardioversion.
研究概览
简要总结
This study investigates whether a smartphone application that measures heart rhythm using light, a technique known as photoplethysmography or PPG, can accurately detect when the cardiac arrhythmia atrial fibrillation (AF) spontaneously terminates and the heart returns to normal sinus rhythm. This is a prospective, multicentre randomised controlled study conducted at Hospital East Limburg and University Hospitals Leuven.
Continuous heart rhythm monitoring with conventional equipment is often not feasible in the home setting because of the high cost and complexity of the equipment. Smartphone-based PPG monitoring offers a practical and affordable alternative. The study will include 200 adult patients with known AF who are scheduled for elective electrical cardioversion. Patient will be randomised to either standard of care (no remote monitoring) or smartphone-based PPG monitoring. During the seven days preceding the procedure, participants in the intervention group will perform PPG and ECG measurements at predefined times using their smartphone and a chest strap.
The primary objective is to determine whether this intermittent, app-guided monitoring can detect spontaneous conversion to normal sinus rhythm before the planned cardioversion, thereby preventing unnecessary hospital admissions. In addition, we will evaluate the relationship between symptoms and cardiac rhythm, adherence to and user experience with self-monitoring, and the predictive value of the measured parameters for recurrence of AF or atrial flutter during one year of follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Provide signed and dated informed consent
- •Males or females aged ≥ 18 years
- •Diagnosis of atrial fibrillation based on ECG in medical history
- •Patient in atrial fibrillation when planned for electrical cardioversion as evidenced by an ECG
- •In possession of a smartphone
- •Being able and having the time to perform heart rhythm measurement using the FibriCheck application at home
排除标准
- •Cardiac implantable devices such as pacemakers, CRT's or ICD's.
- •No access to a smartphone or unable to perform PPG measurements independently.
- •Active follow-up in Fibricheck care pathways
研究组 & 干预措施
Intervention arm (PPG-based monitoring)
Twice daily smartphone based PPG assessment of current heart rhythm in the 7 days before planned electrical cardioversion.
干预措施: Smartphone-based PPG monitoring (Device)
Control arm
No additional remote monitoring before planned electrical cardioversion.
结局指标
主要结局
Cancellation of planned admission for electrical cardioversion.
时间窗: From date of randomization until the initial date of planned admission for electrical cardioversion, assessed up to 8 weeks.
Cancellation of planned admission for electrical cardioversion.
次要结局
- Spontaneous reconversion rate(From date of randomization until the initial date of planned admission for electrical cardioversion, assessed up to 8 weeks.)
- Cost analysis of systematic PPG monitoring prior to cardioversion.(From date of randomization until the initial date of planned admission for electrical cardioversion, assessed up to 8 weeks.)
- AF or Aflutter recurrence rate post-cardioversion(from planned admission until 30 days afterwards)
- AF or Aflutter recurrence rate during 1 year follow-up.(From planned admission until 1 year of follow-up.)
- Time to AF or Aflutter recurrence.(From planned admission until 1 year of follow up)
- Electrical cardioversion rate during 1 year follow-up.(From planned admission until 1 year of follow-up.)
- Hazard ratio for AF or atrial flutter recurrence per 10-point increase in the AI-enabled ECG-derived AF risk score(AI-ECG score assessed using the prespecified sinus-rhythm ECG. Recurrence assessed through one year after planned admission)
- Odds ratio for spontaneous reconversion per 10-point increase in the AI-enabled ECG-derived AF risk score(AI-ECG score assessed using the last available sinus-rhythm ECG before date of randomization. Spontaneous cardioversion assessed from date of randomization until the initial date of planned admission for electrical cardioversion, assessed up to 8 weeks.)
- Prediction analysis for spontaneous conversion to sinus rhythm before admission.(From date of randomization until the initial date of planned admission for electrical cardioversion, assessed up to 8 weeks.)
- Prediction analysis for AF/Aflutter recurrence during one year follow-up.(From enrollment until one year of follow-up after planned admission.)
- Patient-reported AFEQT overall score and domain scores at baseline and 30-day follow-up.(From enrollment until 30 days of follow-up after planned admission.)
- The accuracy of smartphone-based PPG monitoring in detecting spontaneous reconversion of AF in patients planned for electrical cardioversion(From date of randomization until the initial date of planned admission for electrical cardioversion, assessed up to 8 weeks.)
- Paroxysmal AF detection rate(From date of randomization until the initial date of planned admission for electrical cardioversion, assessed up to 8 weeks.)
- Missed AF or Aflutter event rate using PPG monitoring.(From date of randomization until the initial date of planned admission for electrical cardioversion, assessed up to 8 weeks.)
- Other arrhythmia detected by single lead ECG.(From date of randomization until the initial date of planned admission for electrical cardioversion, assessed up to 8 weeks.)
- Conversion rate to other type of atrial arrhythmia (Atrial tachycardia, atrial flutter or AF).(From date of randomization until the initial date of planned admission for electrical cardioversion, assessed up to 8 weeks.)
- Mean absolute difference between PPG-derived and ECG-derived heart rate(From date of randomization until the initial date of planned admission for electrical cardioversion, assessed up to 8 weeks.)
- Symptom rate during rhythm assessments.(From enrolment until 30 days after planned admission.)
- Correlation analysis of clinical parameters and symptomatic AF/Aflutter recording rate as well as the SRC index.(From enrolment until 30 days after planned admission.)
- Weekly alcohol consumption(From enrollment until one year follow up after planned admission. Recurrence status assessed through one year)
- Number of days with alcohol consumption per week(From enrolment until 30 days of follow-up. Recurrence status assessed through one year.)
- Weekly caffeine consumption(From enrolment until 30-days of follow up. Recurrence status assessed through one year.)
- Number of days with caffeine consumption per week(From enrolment until 30-days of follow up. Recurrence status assessed through one year.)
- Odds ratio for spontaneous reconversion per additional weekly alcohol unit at enrollment(Alcohol consumption assessed at enrollment. Spontaneous reconversion assessed from date of randomization until the initial date of planned admission for electrical cardioversion, assessed up to 8 weeks.)
- Odds ratio for spontaneous reconversion per additional day of alcohol consumption per week at enrollment(Alcohol consumption frequency assessed at enrollment. Spontaneous reconversion assessed from date of randomization until the initial date of planned admission for electrical cardioversion, assessed up to 8 weeks.)
- Odds ratio for spontaneous reconversion per additional weekly caffeine serving at enrollment(Caffeine consumption assessed at enrollment. Spontaneous reconversion assessed from date of randomization until the initial date of planned admission for electrical cardioversion, assessed up to 8 weeks.)
- Odds ratio for spontaneous reconversion per additional day of caffeine consumption per week at enrollment(Caffeinated beverage consumption frequency assessed at enrollment. Spontaneous reconversion assessed from date of randomization until the initial date of planned admission for electrical cardioversion, assessed up to 8 weeks.)
- Patient adherence with self-monitoring.(From enrolment until 30 days after planned admission)
- Patient motivation with self-monitoring.(From enrolment until 30 days after planned admission.)