Non-pharmacological Prevention of Stroke in Patients With Non-valvular Atrial Fibrillation

Left atrial appendage (LAA) occlude devices are used for over ten years. According to current data efficiency and safety of this approach at least comparable with pharmacological prevention of stroke in patients with non-valvular atrial fibrillation.

However, to date, LAA occluder implantation is not recommended as an alternative for conservative therapy and reserved for patients with contraindications for oral anticoagulants only. In the same time, long-term follow-up of patients enrolled in clinical trials and data from registries showed that LAA occlude device implantation as an alternative to oral anticoagulation could reduce drug load, decrease complexity and cost of treatment and thus improve patients' quality of life, and potentially may reduce the risk of death. The aim of our study is to investigate the risk of all-cause death, stroke, and bleedings in patients with LAA occluder implanted as an alternative to anticoagulant therapy.

Three hundred patients with atrial fibrillation will undergo LAA occluder implantation. For LAA occluder sizing transesophageal echocardiography (TEE), CT and LAA angiography will be performed. The follow-up period will be 36 months. The incidence of all-cause death, stroke, bleeding BARC≥2, device-related complications and QOL will be investigated.

The patients will be followed in the clinic at three and six months, and then at 12, 24 and 36 months, the telephone calls for getting information about endpoints events will be done. Additional in clinic visits will be scheduled if the late complications will be suspected.

TEE will be performed at three and six months to check for device leak, displacement and thrombosis.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: left atrial appendage occluder implantation

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 101990
    • . National Research Center for Preventive Medicine of the Ministry of Health

Participation Criteria

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

Patients >18 years old with atrial fibrillation and high risk for tromboembolic events

Description

Inclusion Criteria:

• Patient with paroxysmal/persistent/permanent atrial fibrillation
• CHA2DS2VASc score ≥2 for male and ≥3 for female
• Without contraindications to anticoagulation therapy

Exclusion Criteria:

• LAA thrombosis
• mechanical prosthetic heart valve
• moderate or severe mitral valve stenosis

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with Composite of death, stroke, clinically significant bleeding event (>_2 class according to BARC criteria), device leak, device displacement or device thrombosis with the first event for a given patient is taken into account	a clinically significant bleeding event is >_2 class according to Bleeding Academic Research Consortium (BARC) criteria bleeding	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
device thrombosis during first 6 months	device thrombosis detected by transesophageal echocardiography during first 6 months of follow-up	6 months
device dislocation	number of patients who would have device dislocation	36 months
any bleed	total number of patients who would have any bleeding event	36 months
bleeding BARC ≥2	total number of patients who would have bleeding event with the grade BARC ≥2	36 months
device leak and displacement during first 6 months	device leak detected by transesophageal echocardiography during first 6 months after implantation or device displacement during the same time period	6 months
any adverse events during 7 days after LAA occluder implantation	any adverse events related to the device implantation during the first 7 days after implantation	7 days
change in QOL SF 36 between baseline and final visit	change in quality of life (QOL) by Short Form (SF) 36 Health Survey between baseline and follow-up visits SF 36 is a 36-item, patient-reported survey of patient health. SF-36 measures the subject's overall Health Related Quality of Life on 8 domains: physical functioning, role functioning, bodily pain, general health, vitality, social functioning, role emotional and mental health. 0-100 scale are using to access each domain. lower the score the more disability.	Assessed at baseline and 6-month follow-up visits
the percent of patients in whom long -term anticoagulation therapy would add during follow-up	number of patients who would require adding permanent anticoagulant therapy for any reason during follow-up	36 months

Collaborators and Investigators

• Sponsor: National Research Center for Preventive Medicine
• Collaborators: I.M. Sechenov First Moscow State Medical University; National Medical Research Center for Cardiology, Ministry of Health of Russian Federation; National Research Center of Surgery, Russia; Medical and Rehabilitation center
• Investigators: Principal Investigator: Karapet Davtyan, National Research Center for Preventive Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: February 6, 2019
• First Submitted That Met QC Criteria: March 6, 2019
• First Posted (Actual): March 7, 2019

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: atrial fibrillation; left atrial appendage; LAA occluder; thromboembolic prophylaxis
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 2018/10/21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No