Russian National Registry of LAAO

Russian National Registry of Left Atrial Appendage Occlusion

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04322474

Enrollment

200

Registered

2020-03-26

Start date

2015-09-01

Completion date

2018-12-31

Last updated

2020-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation, left atrial appendage, stroke prevention, occluder, Watchman device, Amplatzer Cardiac Plug

Brief summary

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.

Interventions

DEVICECatheter-based left atrial appendage occlusion

Catheter-based implantation of left atrial appendage occluder

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Procedure-related major adverse events (pericardial effusion, cardiac tamponade, device embolization, procedure/device-related death)	12 months	—
The composite of thromboembolic events, device thrombosis, hemorrhagic events, unexplained death	12 months	Primary efficacy endpoint

Secondary

Measure	Time frame	Description
Procedure success rate	intraprocedural	successful left atrial appendage occluder implantation rate
Peridevice leakage	6 months	incidence rates of significant (≥5mm) leakage

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026