Clinical trial NCT03867227: Non-pharmacological Prevention of Stroke in Patients With Non-valvular Atrial Fibrillation
Official title: Non-pharmacological Prevention of Stroke in Patients With Non-valvular Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: left atrial appendage
LAA occluder
thromboembolic prophylaxis
atrial fibrillation
Lead sponsor: National Medical Research Center for Therapy and Preventive Medicine
Sponsor class: OTHER_GOV
Collaborators: name: National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
name: National Research Center of Surgery, Russia
name: I.M. Sechenov First Moscow State Medical University
name: Medical and Rehabilitation center
First posted: 2019-03-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients \>18 years old with atrial fibrillation and high risk for tromboembolic events

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.


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

Primary outcomes:
measure: 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
timeFrame: 36 months
Secondary outcomes:
measure: device thrombosis during first 6 months
timeFrame: 6 months
measure: device dislocation
timeFrame: 36 months
measure: any bleed
timeFrame: 36 months
measure: bleeding BARC ≥2
timeFrame: 36 months
measure: device leak and displacement during first 6 months
timeFrame: 6 months
measure: any adverse events during 7 days after LAA occluder implantation
timeFrame: 7 days
measure: change in QOL SF 36 between baseline and final visit
timeFrame: Assessed at baseline and 6-month follow-up visits
measure: the percent of patients in whom long -term anticoagulation therapy would add during follow-up
timeFrame: 36 months
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: . National Research Center for Preventive Medicine of the Ministry of Health
Study officials:
affiliation: National Research Center for Preventive Medicine
name: Karapet Davtyan
role: PRINCIPAL_INVESTIGATOR
References: