MedTrace Logo

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

NCT03867227 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2023-03-29

No results posted yet for this study

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

Interventions

DEVICE

left atrial appendage occluder implantation

all patients will get implantation of LAA occluder

Sponsors & Collaborators

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

    collaborator OTHER_GOV

  • National Research Center of Surgery, Russia

    collaborator OTHER_GOV

  • I.M. Sechenov First Moscow State Medical University

    collaborator OTHER

  • Medical and Rehabilitation center

    collaborator UNKNOWN

  • National Research Center for Preventive Medicine

    lead OTHER_GOV

Principal Investigators

  • Karapet Davtyan · National Research Center for Preventive Medicine

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-01
Primary Completion
2021-12-01
Completion
2022-12-01

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03867227 on ClinicalTrials.gov