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

NCT03867227 | Completed

• 1 other identifier: 2018/10/21
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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

Keywords

left atrial appendage; LAA occluder; thromboembolic prophylaxis; atrial fibrillation

Outcome Measures

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

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

  36 months

Secondary Outcomes (8)

• device thrombosis during first 6 months

  6 months

• device dislocation

  36 months

• any bleed

  36 months

• bleeding BARC ≥2

  36 months

• device leak and displacement during first 6 months

  6 months

Interventions

left atrial appendage occluder implantation DEVICE

all patients will get implantation of LAA occluder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

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

Moscow, 101990, Russia

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Karapet Davtyan

  National Research Center for Preventive Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2019
• First Posted: March 7, 2019
• Study Start: December 1, 2018
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: March 29, 2023

Record last verified: 2023-03

Locations

RU (1)