Russian National Registry of LAAO

National Research Center for Preventive Medicine200 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Atrial Fibrillation

Interventions

Catheter-based left atrial appendage occlusionDEVICE

Catheter-based implantation of left atrial appendage occluder

Eligibility

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Procedure-related major adverse events (pericardial effusion, cardiac tamponade, device embolization, procedure/device-related death)

Time frame: 12 months

The composite of thromboembolic events, device thrombosis, hemorrhagic events, unexplained death

Primary efficacy endpoint

Time frame: 12 months

Secondary Outcomes

Procedure success rate

successful left atrial appendage occluder implantation rate

Time frame: intraprocedural

Peridevice leakage

incidence rates of significant (≥5mm) leakage

Time frame: 6 months