D-dimer Assay for the Exclusion of Intra-atrial Thrombus Risk Before Ablation of Atrial Fibrillation

October 26, 2023 updated by: Groupe Hospitalier de la Rochelle Ré Aunis

Etude du Dosage Des d-dimères sériques Pour le Diagnostic d'Exclusion Des Thrombi Intra-atriaux Avant Ablation Endocavitaire de Fibrillation Atriale

The purpose of this study is to determine whether D-dimer dosage allow to exclude risk of intraatrial thrombus before performing an ablation of atrial fibrillation

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2506

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Annecy, France
        • Service de cardiologie, CH de la Région d'Annecy
      • Auxerre, France
        • Centre Hospitalier d' Auxerre
      • Avignon, France
        • Service de cardiologie, CH Avignon
      • Bayonne, France
        • Clinique La Fourcade
      • Bordeaux, France
        • Service de cardiologie, CHU Bordeaux
      • Brest, France
        • Service de cardiologie, CHU Brest
      • Caen, France
        • Service de cardiologie, CHU Caen
      • Clermont Ferrand, France
        • Service de cardiologie, CHU Clermont Ferrand
      • Créteil, France
        • Service de cardiologie, AP Hôpital Henri Mondor
      • Dijon, France
        • Service de cardiologie, CHU Dijon
      • La Rochelle, France, 17019
        • Groupe Hospitalier de la Rochelle Ré Aunis
      • Le Mans, France
        • Service de cardiologie, CH Le Mans
      • Limoges, France
        • Service de cardiologie, CHU Limoges
      • Lyon, France
        • Service de cardiologie, HCL Groupement Est
      • Marseille, France
        • Service de cardiologie, APM Hôpital de La Timone
      • Marseille, France
        • Service de cardiologie, CHI Aix Pertuis CHPA-CHIAP
      • Marseille, France
        • Service de cardiologie, Hôpital Saint Joseph
      • Massy, France
        • Service de cardiologie, Institut Jacques Cartier
      • Metz, France
        • Service de cardiologie, CHR Metz Thionville
      • Montfermeil, France
        • Service de cardiologie, CHI Le Raincy Montfermeil
      • Nancy, France
        • Service de cardiologie, CHU Nancy
      • Nantes, France
        • Service de cardiologie, Nouvelles Cliniques Nantaises
      • Nîmes, France
        • Service de cardiologie, CHU Nîmes
      • Nîmes, France
        • Service de cardiologie, HP Les Franciscaines
      • Paris, France
        • Service de cardiologie, AP Hôpital la Pitié Salpêtrière
      • Paris, France
        • Service de cardiologie, Groupe Hospitalier Bichat Claude Bernard
      • Paris, France
        • Service de cardiologie, Institut Mutualiste Montsouris
      • Pau, France
        • Service de cardiologie, CH Pau
      • Poitiers, France
        • Service de cardiologie, CHU Poitiers
      • Rennes, France
        • Service de cardiologie, CHU Rennes
      • Rouen, France
        • Service de cardiologie, CHU Rouen
      • Saint Denis, France
        • Service de cardiologie, Centre Cardiologique du Nord
      • Saint Etienne, France
        • Service de cardiologie, CHU Saint Etienne
      • Toulouse, France
        • Service de cardiologie, CHU Toulouse Hôtel Dieu St Jacques
      • Tours, France
        • Service de cardiologie, Clinique Saint Gatien
      • Trélaze, France
        • Service de cardiologie, Clinique Saint Joseph
      • Valenciennes, France
        • Service de cardiologie, Polyclinique Vauban

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age> 18 years.
  • Patients hospitalized for ablation of atrial fibrillation or symptomatic left flutter
  • Patient informed of the study

Exclusion Criteria:

  • Age <18 years.
  • Patients under guardianship
  • Pregnant woman
  • Contraindication to transesophageal echocardiography
  • transesophageal echocardiography made in another center as the center of ablation
  • Refusal of the patient to participate in the study
  • Patient participating in another interventional study in which an intervention related to biomedical research is performed before the transesophageal echocardiography

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Atrial fibrillation
D-dimer assay before ablation of atrial fibrillation
Other: D-dimer assay before ablation of atrial fibrillation
Blood sample collection for D-dimers measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Patients With Atrial Thrombus Diagnosed by Transoesophageal Ultrasound
Time Frame: up to 48 hours before ablation
up to 48 hours before ablation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CHADS2 Score
Time Frame: 48 hours before ablation
CHADS2 score (congestive heart failure=1, hypertension=1, diabetes mellitus=1, history of stroke or transient ischemic attack=1, and age under 75=1)
48 hours before ablation
Risk Factors
Time Frame: 48 hours before ablation
variables related to the presence of atrial thrombus
48 hours before ablation
Atrial Thrombus Exclusion (ATE) Score
Time Frame: 48 hours before ablation

The following thromboembolic risk factors mark 1 point if present in patient:

  • hypertension = 1 point
  • cardiac insufficiency = 1 point
  • history of stoke = 1 point
  • d-dimer level >270ng/mL = 1 point The sum corresponds to the ATE score
48 hours before ablation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier de la Rochelle Ré Aunis

Collaborators

Medtronic

Investigators

  • Principal Investigator: Antoine MILHEM, MD, Groupe Hospitalier de la Rochelle Ré Aunis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 28, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

July 22, 2014

First Submitted That Met QC Criteria

July 23, 2014

First Posted (Estimated)

July 24, 2014

Study Record Updates

Last Update Posted (Actual)

October 30, 2023

Last Update Submitted That Met QC Criteria

October 26, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014/P02/001
  • 2013-A01700-45 (Other Identifier: French National Agency for Medicines/Health Products Safety)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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