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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03867227
• Other study ID #: 2018/10/21
• Status: Completed
• Start date: December 1, 2018
• Est. completion date: December 1, 2022

Study information

• Verified date: March 2023
• Source: National Medical Research Center for Therapy and Preventive Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• left atrial appendage occluder implantation
all patients will get implantation of LAA occluder

Locations

Country	Name	City	State
Russian Federation	. National Research Center for Preventive Medicine of the Ministry of Health	Moscow

Sponsors (5)

Lead Sponsor	Collaborator
National Research Center for Preventive Medicine	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

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	device thrombosis during first 6 months	device thrombosis detected by transesophageal echocardiography during first 6 months of follow-up	6 months
Secondary	device dislocation	number of patients who would have device dislocation	36 months
Secondary	any bleed	total number of patients who would have any bleeding event	36 months
Secondary	bleeding BARC =2	total number of patients who would have bleeding event with the grade BARC =2	36 months
Secondary	device leak and displacement during first 6 months	device leak detected by transesophageal echocardiography during first 6 months after implantation or device displacement during the same time period	6 months
Secondary	any adverse events during 7 days after LAA occluder implantation	any adverse events related to the device implantation during the first 7 days after implantation	7 days
Secondary	change in QOL SF 36 between baseline and final visit	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.	Assessed at baseline and 6-month follow-up visits
Secondary	the percent of patients in whom long -term anticoagulation therapy would add during follow-up	number of patients who would require adding permanent anticoagulant therapy for any reason during follow-up	36 months