Abstract
Background: With the increasing number of aged population in China, the mortality and disability caused by atrial fibrillation (AF) and its complications lead to serious social burden and becoming more prominent. Due to the high false-negative rates of AF detected by routine ECG, the results on the recurrent rate and AF burden after cryoballoon ablation (CBA) in real world are inconsistent so far. Since the extension of monitoring time, the increased detection of AF in patients, insertable cardiac monitor (ICM) has its unique merits. Methods: Cryo-ICM AF study is a prospective, multicenter randomized controlled trial with 200 participants with paroxysmal atrial fibrillation from 4 centers. Monitoring AF load after CBA though two monitoring methods— ICM and 24 hours holter during the 1 years follow-up of the two groups. All data will be observed and recorded in baseline, 30th days and 3 th , 6 th , 9 th and 12 th months after CBA, which including incidence rates of postoperative complications and recurrence conditions, cardioelectrical indexes from 24-hours holter in all subjects and ICM in ICM group, UCG parameters about atrium/ventricular size and diastolic/systolic function, and biochemical indicators. Disucssion: This is the first study design to confirm the effectiveness of cryoballoon in real world, monitoring AF load with ICM in patients with paroxysmal AF after CBA.Trial registration: Chinese Clinical Trial Registry, No. ChiCTR1900026364. Registered 9 Oct 2019, http://www.chictr.org.cn/index.aspx
Real-world Adoption of Smartphone-based Remote Monitoring Using the Confirm Rx™ Insertable Cardiac Monitor
