Russian National Registry of LAAO

March 25, 2020 updated by: National Research Center for Preventive Medicine

Russian National Registry of Left Atrial Appendage Occlusion

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Nonvalvular atrial fibrillation patients with a high risk of thromboembolic and haemorrhagic events

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Research Center for Preventive Medicine

Investigators

  • Principal Investigator: Karapet Davtyan, PhD, National Research Center for Preventive Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

December 30, 2017

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

March 24, 2020

First Submitted That Met QC Criteria

March 25, 2020

First Posted (Actual)

March 26, 2020

Study Record Updates

Last Update Posted (Actual)

March 26, 2020

Last Update Submitted That Met QC Criteria

March 25, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8-5

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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