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OpenTrials
Completed

NCT Number: NCT04322474

Russian National Registry of LAAO

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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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Catheter-based left atrial appendage occlusion

Device

Catheter-based implantation of left atrial appendage occluder

Primary outcomes

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

    Time frame: 12 months

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

    Time frame: 12 months

    Primary efficacy endpoint

Secondary outcomes

  1. Procedure success rate

    Time frame: intraprocedural

    successful left atrial appendage occluder implantation rate

  2. Peridevice leakage

    Time frame: 6 months

    incidence rates of significant (≥5mm) leakage

Sponsors and collaborators

Lead sponsor

National Research Center for Preventive Medicine

Other Gov

Registry information

Official study title

Russian National Registry of Left Atrial Appendage Occlusion

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Mar 26, 2020
Registry last updated
Mar 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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