Assessing bleeding and thromboembolic risks in patients with atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to develop and validate a composite risk score that predicts both ischemic and bleeding risks in patients with non-valvular atrial fibrillation (NVAF). The researchers will first evaluate the predictive performance of existing clinical risk scores and then assess the potential value of additional markers. Ultimately, they aim to create a new risk score that could improve treatment decisions for patients with NVAF. The study will involve collecting epidemiologic, clinical, biological, and morphologic data from participants.

Why it matters

Who can join: the full rules

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's running

• Service de cardiologie - hôpital Saint Antoine
  Paris, France Recruiting
• Centre Cardiologique du Nord
  Saint-Denis, France Recruiting
• Service de cadiologie - Hôpital Pitié Salpêtrière
  Paris, France Suspended
• Service de cardiologie - Clinique Pasteur
  Toulouse, France Suspended

Study contacts

• Principal investigator: Ariel Cohen, Md, PhD — AP-HP, Hôpital Saint-Antoine, Service de cardiologie, 75012 Paris, France
• Study coordinator: Ariel Cohen, MD, PhD
• Email: ariel.cohen@aphp.fr
• Phone: +33149282886

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.