Single-center Pilot Study to Evaluate the Interest of a Hybrid Connected Watch for Heart Rate Monitoring in Postoperative Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- To compare the rate of recurrence of paroxysmal or persistent atrial fibrillation with continuous 12-month postoperative cardiac surgery monitoring in patients with POAF versus traditional follow-up with ECG recording at 3, 6 and 12 months
研究概览
简要总结
The objective of this single-center pilot study is, with the help of a connected watch, to show the absence of recurrence or maintenance of sinus rhythm in patients with a Post Operative Atrial Fibrillation (POAF) and to help treating cardiologists in the care of these patients.
研究设计
- 研究类型
- 观察性
- 观察模型
- 其他
- 时间视角
- 前瞻性
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
- Major with an indication for conventional cardiac surgery with de novo postoperative AF onset.
- Agreeing to participate in the study and having signed an informed consent.
- Agreeing to undergo 12 months of postoperative monitoring.
排除标准
- Patient with pre-operative AF
- Patient who does not have a smartphone compatible with the connected watch.
- Patient unable to perform an ECG measurement independently.
- Patient with a physical constraint to the measurement (arteriovenous fistula...)
- Minors
- Pregnant or breast-feeding women
- Adults under guardianship, under curatorship
- Patients whose life expectancy is less than 1 year
- Patients participating in another therapeutic trial likely to impact the evaluation criteria of the MONHYCARD study
- Contraindication to long-term anticoagulants
- Patients implanted with a mechanical valve prosthesis pre-operatively or after surgery
研究组 & 干预措施
Electrocardiogram
干预措施: Clinical follow-up (ECG) (Other)
Electrocardiogram + Connect Watch
干预措施: Clinical follow-up (ECG) (Other)
Electrocardiogram + Connect Watch
干预措施: Ongoing monitoring (Other)
结局指标
主要结局
To compare the rate of recurrence of paroxysmal or persistent atrial fibrillation with continuous 12-month postoperative cardiac surgery monitoring in patients with POAF versus traditional follow-up with ECG recording at 3, 6 and 12 months
时间窗: 12 months
Recurrence rate of paroxysmal or persistent Atrial Fibrillation (AF) (ESC 2020 Definition) over a 12-month follow-up period post cardiac surgery according to traditional ECG monitoring at 3, 6, and 12 months more or less combined with connected watch monitoring
次要结局
- Evaluation of complication rates related to the different treatments according to the follow-up modality(12 months)
- Evaluate the appropriateness of each of the two modalities with treating cardiologists(12 months)
- Assessment of the rate of patients on anticoagulant therapy by follow-up modality(12 months)
- Assessment of the duration of AF transitions(12 months)
- Assessment of the number of patients in AF(12 months)
- Assessment of quality of life and satisfaction with use by follow-up modality(12 months)
研究者
研究点 (1)
标识符
- NCT 编号
- NCT05664308
- 其他研究编号
- RC22_0604
日期
- 首次提交
- (3年前)
- 首次发布
- (3年前)
- 主要完成日期
- (明年)
- 研究完成日期
- (2年后)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- UNDECIDED
- 是否有结果
- 否