NCT02741349Recruiting
Thromboembolic and Bleeding Risk Stratification in Patients With Non-valvular Atrial Fibrillation
Impact of Clinical, Echocardiographic and Biological Parameters to the Risk of Cardiovascular Disease in Patients With Non-valvular Atrial Fibrillation.
Source: ClinicalTrials.gov · Last updated 16 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 825 (estimated)
- First submitted
- 7 Apr 2016
- Start date
- 27 Jul 2015
- Primary completion date
- Dec 2025
- Lead sponsor
- Saint Antoine University Hospital
- Diseases
- Atrial fibrillation
- NCT number
- NCT02741349
What you commit to
- Study type: Observational
- Planned participants: 825
- From 27 Jul 2015 to the primary completion date, Dec 2025
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
- Severe psychiatric history
Other
- Presence of a contraindication to long term anticoagulant treatment
- Absence of social security coverage
- Impossibility of follow-up
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Service de cadiologie - Hôpital Pitié Salpêtrière Coordinator of this site? Confirm its status | Paris | France | Suspended |
| Service de cardiologie - hôpital Saint Antoine Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Centre Cardiologique du Nord Coordinator of this site? Confirm its status | Saint-Denis | France | Recruiting |
| Service de cardiologie - Clinique Pasteur Coordinator of this site? Confirm its status | Toulouse | France | Suspended |
This page is information, not medical advice. Discuss any trial with your doctor.