Russian National Registry of LAAO
1 other identifier
observational
200
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2015
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedFirst Submitted
Initial submission to the registry
March 24, 2020
CompletedFirst Posted
Study publicly available on registry
March 26, 2020
CompletedMarch 26, 2020
March 1, 2020
2.3 years
March 24, 2020
March 25, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Primary efficacy endpoint
12 months
Secondary Outcomes (2)
Procedure success rate
intraprocedural
Peridevice leakage
6 months
Interventions
Catheter-based implantation of left atrial appendage occluder
Eligibility Criteria
Nonvalvular atrial fibrillation patients with a high risk of thromboembolic and haemorrhagic events
You may qualify if:
- age ≥18 years nonvalvular atrial fibrillation,
- CHA2DS2VASc ≥2,
- high risk of hemorrhagic events,
- non-compliance with pharmacological anticoagulant therapy
You may not qualify if:
- significant mitral valve disease,
- left ventricular ejection fraction \<35%,
- the tendency to systemic thrombosis,
- severe co-morbidities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karapet Davtyan, PhD
National Research Center for Preventive Medicine
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2020
First Posted
March 26, 2020
Study Start
September 1, 2015
Primary Completion
December 30, 2017
Study Completion
December 31, 2018
Last Updated
March 26, 2020
Record last verified: 2020-03