Russian National Registry of LAAO

Atrial Fibrillation Clinical Trial

Official title:

Russian National Registry of Left Atrial Appendage Occlusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04322474
• Other study ID #: 8-5
• Status: Completed
• Start date: September 1, 2015
• Est. completion date: December 31, 2018

Study information

• Verified date: March 2020
• Source: National Research Center for Preventive Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 31, 2018
• Est. primary completion date: December 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Catheter-based left atrial appendage occlusion
Catheter-based implantation of left atrial appendage occluder

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Research Center for Preventive Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedure-related major adverse events (pericardial effusion, cardiac tamponade, device embolization, procedure/device-related death)		12 months
Primary	The composite of thromboembolic events, device thrombosis, hemorrhagic events, unexplained death	Primary efficacy endpoint	12 months
Secondary	Procedure success rate	successful left atrial appendage occluder implantation rate	intraprocedural
Secondary	Peridevice leakage	incidence rates of significant (=5mm) leakage	6 months