Russian National Registry of LAAO

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-01

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Catheter-based left atrial appendage occlusion

Catheter-based implantation of left atrial appendage occluder

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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