Russian National Registry of LAAO

National Research Center for Preventive Medicine

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Device: Catheter-based left atrial appendage occlusion

Study type: Observational

Funder types: Other

Identifiers

NCT04322474

8-5

Details and patient eligibility

About

The first Russian registry presents data from two hundred consecutive patients with nonvalvular atrial fibrillation, who undergone left atrial appendage occlusion (LAAO) using the Watchman device and the Amplatzer cardiac plug. This government-funded catheter-based LAAO program was started in September 2015 and was completed in December 2017. Data collection was finished in December 2018. Five clinics agreed to participate in the study.

Patients' baseline characteristics, procedure, and follow up data were collected according to established registry protocol. Patients were followed at 45 days, 3, 6 and 12 months after enrollment. At each follow-up visit, the data regarding clinical events and healthcare utilization was collected.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age ≥18 years nonvalvular atrial fibrillation,
• CHA2DS2VASc ≥2,
• high risk of hemorrhagic events,
• non-compliance with pharmacological anticoagulant therapy

Exclusion criteria

• significant mitral valve disease,
• left ventricular ejection fraction <35%,
• the tendency to systemic thrombosis,
• severe co-morbidities