AnticoaguLation ONE Year After Ablation of Atrial Fibrillation in Patients With Atrial Fibrillation (ALONE AF Study)
Recruiting · NCT04432220 · Interventional (participants receive a specific treatment) · Lead sponsor: Yonsei University
View the official record on ClinicalTrials.gov →Interventions studied
Anticoagulation group(Apixaban group)
What this trial is about
There has no evidence for the anticoagulation in patients who had undergone catheter ablation of atrial fibrillation, and has maintained sinus rhythm for more than 1 year. However, anticoagulation can increase the risk of bleeding, the study evaluating the role of oral anticoagulation is needed in this patients. This study will compare the efficacy and safety of non-vitamin K anticoagulants (apixaban) and no oral anticoagulation in patient with sinus rhythm one year after catheter ablation of AF.
Who can take part
Age range
19 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- no recurrence of atrial fibrillation one year after catheter ablation of atrial fibrillation
- CHA2DS2-VASc score \>=1 (male) or \>=2 (female)
- age: 19 to 80 years
- non-valvular atrial fibrillation
- those who consent the study.
- those who can be followed after enrollment
Exclusion criteria
- Severe liver or kidney dysfunction
- Thyroid dysfunction
- Pregnant or breastfeeding women
- Malignant tumors that have not been completely cured
- Severe structural heart disease
- Predicted survival is less than 12 months
- Patients who do not understand the content of the study or disagree with it
Where it is running
1 location listed.
- Severance Cardiovascular Hospital Yonsei University - Seoul, South Korea