Thromboembolic and Bleeding Risk Stratification in Patients With Non-valvular Atrial Fibrillation
Recruiting · NCT02741349 · Observational (researchers observe without assigning treatment) · Lead sponsor: Saint Antoine University Hospital
View the official record on ClinicalTrials.gov →What this trial is about
The aim of the present prospective study is to further develop and validate a composite risk score predicting both ischemic and bleeding risk, based on epidemiologic, clinical, biological, and/or morphologic complementary data. First, the investigators will assess the predictive performance of current clinical risk scores. Second, the investigators will assess the potential predictive value of additional markers. Third, the investigators will aim to develop a new risk score.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Adults above 18 years of age
- Presenting a NVAF which is paroxysmal, persistent or permanent and documented by an electrocardiogram (ECG)
- Willing and able to give written informed consent
Exclusion criteria
- Patients presenting a clinically and echocardiographically significant valve disease defined as :
- mitral stenosis with a valve area \< 2cm2
- mitral insufficiency (grade 3 or 4)
- aortic insufficiency (grade 3 or 4)
- tricuspid insufficiency (grade 3 or 4)
- aortic stenosis with a valve area \< 1.5 cm2
- mechanical valve prosthèses
- Secondary AF due to an acute cause (thyrotoxicosis, acute pericarditis, infection, systemic disease)
- Presence of a contraindication to long term anticoagulant treatment
- Absence of social security coverage
- Severe psychiatric history
- Impossibility of follow-up
Where it is running
4 locations listed.
- Service de cardiologie - hôpital Saint Antoine - Paris, France
- Service de cadiologie - Hôpital Pitié Salpêtrière - Paris, France
- Centre Cardiologique du Nord - Saint-Denis, France
- Service de cardiologie - Clinique Pasteur - Toulouse, France