Effect of Left Atrial Appendage Velocity on Left Atrial Structure and Function After Radiofrequency Ablation Combined With Left Atrial Appendage Occlusion

NCT04693871 | Completed FDA Device

• 1 other identifier: XieRuiqinLAAEV
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Radiofrequency ablation of atrial fibrillation combined with left atrial appendage closure can not only improve symptoms in patients with non-valvular atrial fibrillation, but also prevent left atrial appendage thrombosis. The safety and effectiveness of left atrial appendage occlusion have been confirmed by randomized controlled trials and actual experience. Among patients with different left atrial appendage emptying speeds, there are limited studies on the structure and function of the left atrial appendage after LAA closure. In this study, patients with persistent nonvalvular atrial fibrillation were selected for radiofrequency ablation combined with LAA closure. The sinus rhythm was restored after the operation. According to the different emptying speed of the left atrial appendage, they were divided into a high-flow rate group and a low-flow rate group. The differences in the structure and function of the left atrium between the two groups were analyzed.

Conditions

Left Atrial Appendage Velocity; Left Atrial Structure; Left Atrial Function

Outcome Measures

Primary Outcomes (2)

• Changes in the structure of the left atrium

  Measure the left atrial transverse diameter, anteroposterior diameter, upper and lower diameter.

  1year

• Changes in the function of the left atrium

  Left atrium volume. Two-chamber and four-chamber left atrium strain and strain rate, left atrium storage function, channel function and pump function.

  1year

Study Arms (2)

high-flow rate group

Device: Transesophageal ultrasound

low-flow rate group

Device: Transesophageal ultrasound

Interventions

Transesophageal ultrasound DEVICE

Patients with nonvalvular atrial fibrillation underwent radiofrequency ablation combined with left atrial appendage closure and recovered to sinus rhythm after the operation. To study the changes of left atrial organization and function of two groups of patients with different left atrial appendage emptying speeds.

Also known as: Radiofrequency ablation of atrial fibrillation combined with left atrial appendage closure

high-flow rate group; low-flow rate group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with non-valvular atrial fibrillation between the ages of 18 and 80 received atrial fibrillation radiofrequency ablation combined with left atrial appendage occlusion, and recovered to sinus rhythm after the operation. According to the different left atrial appendage emptying speed, it is divided into a higher left atrial appendage emptying speed group and a lower left atrial appendage emptying speed group.

You may qualify if:

• Patients who received atrial fibrillation radiofrequency ablation combined with left atrial appendage closure.
• Exclude Criteria
• Patients with incomplete data.
• Device embolism.
• Residual shunt around the device found by transesophageal echocardiography greater than 5 mm.
• Mitral valve stenosis.
• Artificial valve.
• Atrial septal defect.
• Dilated cardiomyopathy
• Moderate Severe mitral regurgitation

Sponsors & Collaborators

• The Second Hospital of Hebei Medical University: lead

Study Sites (1)

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

MeSH Terms

Interventions

Left Atrial Appendage Closure

Intervention Hierarchy (Ancestors)

Cardiac Catheterization; Catheterization; Therapeutics; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Cardiology in the Second Hospital of Hebei Medical University

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: January 5, 2021
• Study Start: January 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: March 18, 2021

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)