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临床试验/NCT06842160
NCT06842160尚未招募不适用

Photoplethysmography (PPG) Algorithm with Smartwatch in Evaluation of Atrial Fibrillation Burden After Catheter Ablation

Beijing Anzhen Hospital1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2025年3月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
10,000
试验地点
1
主要终点
Incidence of Stroke

研究概览

简要总结

The purpose of this study is to evaluate the effectiveness of a smart electrocardiogram watch based on the PPG algorithm in monitoring the atrial fibrillation burden of patients after catheter ablation.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Atrial fibrillation patients diagnosed by electrocardiogram
  • Received catheter ablation procedure
  • Willing to use long-range electrocardiogram monitoring equipment

排除标准

  • 1.Patients who are allergic to electronic devices or unable to wear watches

结局指标

主要结局

Incidence of Stroke

时间窗: March 30, 2025 to March 30, 2035

The rate of stroke occurrences in the study population, measured separately for each participant. The unit of measure will be the frequency of events (e.g., number of strokes per participant).

Incidence of Heart Failure

时间窗: March 30, 2025 to March 30, 2035

The rate of heart failure occurrences in the study population, measured separately for each participant. The unit of measure will be the frequency of events (e.g., number of heart failure episodes per participant).

All-Cause Mortality Rate

时间窗: March 30, 2025 to March 30, 2035

The rate of all-cause mortality in the study population, measured separately for each participant. The unit of measure will be the frequency of events (e.g., number of deaths per participant).

Cardiovascular Mortality Rate

时间窗: March 30, 2025 to March 30, 2035

The rate of cardiovascular-related mortality in the study population, measured separately for each participant. The unit of measure will be the frequency of events (e.g., number of cardiovascular-related deaths per participant).

Rate of Rehospitalization

时间窗: March 30, 2025 to March 30, 2035

The rate of rehospitalization due to any medical cause in the study population. The unit of measure will be the frequency of events (e.g., number of rehospitalization events per participant).

Incidence of Bleeding Events

时间窗: March 30, 2025 to March 30, 2035

The rate of bleeding events (such as major or minor bleeding) in the study population. The unit of measure will be the frequency of events (e.g., number of bleeding events per participant).

Postoperative Atrial Fibrillation Burden

时间窗: March 30, 2025 to March 30, 2035

The frequency and severity of atrial fibrillation episodes observed in participants after a surgical procedure, measured using data collected by an intelligent heart rate monitoring watch utilizing a PPG algorithm. The unit of measure will be frequency of events (e.g., number of episodes per participant).

次要结局

未报告次要终点

研究者

发起方
Beijing Anzhen Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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