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

NCT ID: NCT03867227

Last Updated: 2023-03-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2022-12-01

Brief Summary

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.

Conditions

Atrial Fibrillation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

left atrial appendage occluder implantation

all patients will get implantation of LAA occluder

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Medical Research Center for Cardiology, Ministry of Health of Russian Federation

OTHER_GOV

Sponsor Role: collaborator

National Research Center of Surgery, Russia

OTHER_GOV

Sponsor Role: collaborator

I.M. Sechenov First Moscow State Medical University

OTHER

Sponsor Role: collaborator

Medical and Rehabilitation center

UNKNOWN

Sponsor Role: collaborator

National Research Center for Preventive Medicine

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karapet Davtyan

Role: PRINCIPAL_INVESTIGATOR

National Research Center for Preventive Medicine

Locations

. National Research Center for Preventive Medicine of the Ministry of Health

Moscow, , Russia

Countries

Russia

Other Identifiers

2018/10/21

Identifier Type: -

Identifier Source: org_study_id