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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2506

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Groupe Hospitalier de la Rochelle Ré Aunis

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medtronic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 28, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 22, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 24, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 30, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Atrial Fibrillation

Clinical Trials on D-dimer assay before ablation of atrial fibrillation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings