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Completed

NCT Number: NCT03867227

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Moscow, 101990, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

left atrial appendage occluder implantation

Device

all patients will get implantation of LAA occluder

Primary outcomes

  1. 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

    Time frame: 36 months

    a clinically significant bleeding event is >_2 class according to Bleeding Academic Research Consortium (BARC) criteria bleeding

Secondary outcomes

  1. device thrombosis during first 6 months

    Time frame: 6 months

    device thrombosis detected by transesophageal echocardiography during first 6 months of follow-up

  2. device dislocation

    Time frame: 36 months

    number of patients who would have device dislocation

  3. any bleed

    Time frame: 36 months

    total number of patients who would have any bleeding event

  4. bleeding BARC ≥2

    Time frame: 36 months

    total number of patients who would have bleeding event with the grade BARC ≥2

  5. device leak and displacement during first 6 months

    Time frame: 6 months

    device leak detected by transesophageal echocardiography during first 6 months after implantation or device displacement during the same time period

  6. any adverse events during 7 days after LAA occluder implantation

    Time frame: 7 days

    any adverse events related to the device implantation during the first 7 days after implantation

  7. change in QOL SF 36 between baseline and final visit

    Time frame: Assessed at baseline and 6-month follow-up visits

    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.

  8. the percent of patients in whom long -term anticoagulation therapy would add during follow-up

    Time frame: 36 months

    number of patients who would require adding permanent anticoagulant therapy for any reason during follow-up

Sponsors and collaborators

Lead sponsor

National Research Center for Preventive Medicine

Other Gov

Collaborators

  • I.M. Sechenov First Moscow State Medical University
  • Medical and Rehabilitation center
  • National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
  • National Research Center of Surgery, Russia

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Mar 7, 2019
Registry last updated
Mar 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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