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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03867227
Recruitment Status : Active, not recruiting
First Posted : March 7, 2019
Last Update Posted : December 28, 2021
Sponsor:
Collaborators:
National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
National Research Center of Surgery, Russia
I.M. Sechenov First Moscow State Medical University
Medical and Rehabilitation center
Information provided by (Responsible Party):
National Medical Research Center for Therapy and Preventive Medicine ( National Research Center for Preventive Medicine )

Study Description
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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.


Condition or disease Intervention/treatment
Atrial Fibrillation Device: left atrial appendage occluder implantation

Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-pharmacological Prevention of Stroke in Patients With Non-valvular Atrial Fibrillation
Actual Study Start Date : December 1, 2018
Actual Primary Completion Date : December 1, 2021
Estimated Study Completion Date : August 1, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Device: left atrial appendage occluder implantation
    all patients will get implantation of LAA occluder

Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients >18 years old with atrial fibrillation and high risk for tromboembolic events
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03867227


Locations
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Russian Federation
. National Research Center for Preventive Medicine of the Ministry of Health
Moscow, Russian Federation, 101990
Sponsors and Collaborators
National Research Center for Preventive Medicine
National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
National Research Center of Surgery, Russia
I.M. Sechenov First Moscow State Medical University
Medical and Rehabilitation center
Investigators
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Principal Investigator: Karapet Davtyan National Research Center for Preventive Medicine
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: National Research Center for Preventive Medicine
ClinicalTrials.gov Identifier: NCT03867227    
Other Study ID Numbers: 2018/10/21
First Posted: March 7, 2019    Key Record Dates
Last Update Posted: December 28, 2021
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Medical Research Center for Therapy and Preventive Medicine ( National Research Center for Preventive Medicine ):
left atrial appendage
LAA occluder
thromboembolic prophylaxis
atrial fibrillation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes