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NCT03867227
Non-pharmacological Prevention of Stroke in Patients With Non-valvular Atrial Fibrillation
trial testing left atrial appendage occluder implantation in Atrial Fibrillation in 300 participants. Completed in 1 December 2022.
1 December 2021
Quick facts
| Lead sponsor | National Research Center for Preventive Medicine |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 300 |
| Start date | 1 December 2018 |
| Primary completion | 1 December 2021 |
| Estimated completion | 1 December 2022 |
| Sites | 1 location across Russia |
Drugs / interventions tested
- left atrial appendage occluder implantation
Conditions studied
- Atrial Fibrillation — all drugs for Atrial Fibrillation →
Sponsor
National Research Center for Preventive Medicine
Who can join
18 and older, any sex, with Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03867227
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03867227 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Research Center for Preventive Medicine
- Last refreshed: 29 March 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03867227.
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