NCT03788941

Left Atrial Appendage Closure in Combination With Catheter Ablation

The Efficacy and Safety of Left Atrial Appendage Closure in Combination With Catheter Ablation in Patients With Atrial Fibrillation

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,200 (estimated)
• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

Summary

This study is a prospective cohort study aimed at investigating the efficacy and safety of left atrial appendage closure in combination with catheter ablation in patients with atrial fibrillation.

Detailed description

This study is a prospective cohort investigating the efficacy and safety of catheter ablation in combination with left atrial appendage closure in patients with atrial fibrillation. This study will be conducted in accordance with the following procedures: 1. Screen out patients in accordance with the inclusion and exclusion criteria. The following assessments should be made: demographic data, medical history, physical examination, vital signs data, the height and body weight, laboratory parameters, ECG examination, assessment for medication and evaluation for inclusion/exclusion criteria. 2. Participants receive radiofrequency ablation in combination with left atrial appendage closure. Participants will be assessed and observed carefully during and after the operation. 3. The participants will be followed-up in the third, ninth and twelfth months after the treatments. The main follow-up includes the review of ECG, 24h Holter monitoring, echocardiography, transesophageal echocardiography, coronary CT et al. and AFEQT questionnaire, and brain CT or MRI if necessary. Participants' medication and symptoms will also be observed and recorded. The incidence of stroke, systemic embolism, transient ischemic attack, major bleeding and all-cause death; the rate of patients maintaining sinus rhythm, hospitalization due to heart failure, and perioperative complications such as pericardial tamponade, wound hematoma and long-term surgery-related complications will be recorded. Adverse events during the trial will also be assessed and recorded.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
PROCEDURE	left atrial appendage closure and catheter ablation	Left atrial appendage closure (LAAC) is a treatment strategy to reduce the risk of left atrial appendage blood clots from entering the bloodstream and causing a stroke in patients with non-valvular atrial fibrillation (AF). Catheter ablation is a procedure used to remove or terminate a faulty electrical pathway or pathological sites from sections of the hearts of those who are prone to developing cardiac arrhythmias such as atrial fibrillation, atrial flutter, supraventricular tachycardias (SVT) and Wolff-Parkinson-White syndrome (WPW syndrome). The ablation procedure can be classified by energy source: radiofrequency ablation and cryoablation.

Timeline

• Start date: 2017-01-01
• Primary completion: 2023-12-31
• Completion: 2024-12-31
• First posted: 2018-12-28
• Last updated: 2023-01-19

Locations

1 site across 1 country: China