Russian National Registry of LAAO
- Conditions
- Atrial Fibrillation
- Registration Number
- NCT04322474
- Lead Sponsor
- National Research Center for Preventive Medicine
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- age ≥18 years nonvalvular atrial fibrillation,
- CHA2DS2VASc ≥2,
- high risk of hemorrhagic events,
- non-compliance with pharmacological anticoagulant therapy
- significant mitral valve disease,
- left ventricular ejection fraction <35%,
- the tendency to systemic thrombosis,
- severe co-morbidities
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 12 months Primary efficacy endpoint
- Secondary Outcome Measures
Name Time Method Peridevice leakage 6 months incidence rates of significant (≥5mm) leakage
Procedure success rate intraprocedural successful left atrial appendage occluder implantation rate