Trials / Completed
CompletedNCT03867227
Non-pharmacological Prevention of Stroke in Patients With Non-valvular Atrial Fibrillation
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 300 (actual)
- Sponsor
- National Research Center for Preventive Medicine · Other Government
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | left atrial appendage occluder implantation | all patients will get implantation of LAA occluder |
Timeline
- Start date
- 2018-12-01
- Primary completion
- 2021-12-01
- Completion
- 2022-12-01
- First posted
- 2019-03-07
- Last updated
- 2023-03-29
Locations
1 site across 1 country: Russia
Source: ClinicalTrials.gov record NCT03867227. Inclusion in this directory is not an endorsement.