Actively Recruiting

Age: 18Years +
All Genders
NCT02741349

Thromboembolic and Bleeding Risk Stratification in Patients With Non-valvular Atrial Fibrillation

Led by Saint Antoine University Hospital · Updated on 2025-05-16

825

Participants Needed

4

Research Sites

592 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

Thromboembolic and Bleeding Risk Stratification in Patients With Non-valvular Atrial Fibrillation

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults above 18 years of age
  • Diagnosed with paroxysmal, persistent, or permanent non-valvular atrial fibrillation confirmed by electrocardiogram (ECG)
  • Willing and able to provide written informed consent
Not Eligible

You will not qualify if you...

  • Clinically and echocardiographically significant valve disease, including:
    • Mitral stenosis with valve area less than 2 cm2
    • Mitral insufficiency grade 3 or 4
    • Aortic insufficiency grade 3 or 4
    • Tricuspid insufficiency grade 3 or 4
    • Aortic stenosis with valve area less than 1.5 cm2
    • Mechanical valve prostheses
  • Secondary atrial fibrillation caused by acute conditions such as thyrotoxicosis, acute pericarditis, infection, or systemic disease
  • Contraindication to long-term anticoagulant treatment
  • Lack of social security coverage
  • Severe psychiatric history
  • Inability to complete follow-up

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Service de cardiologie - hôpital Saint Antoine

Paris, France, 75012

Actively Recruiting

2

Service de cadiologie - Hôpital Pitié Salpêtrière

Paris, France, 75013

Suspended

3

Centre Cardiologique du Nord

Saint-Denis, France, 93200

Actively Recruiting

4

Service de cardiologie - Clinique Pasteur

Toulouse, France, 31300

Suspended

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Research Team

A

Ariel Cohen, MD, PhD

CONTACT

S

Sylvie Lang, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Thromboembolic and Bleeding Risk Stratification in Patients With Non-valvular Atrial Fibrillation | DecenTrialz