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Microparticles Circulating Plasma Concentration in Atrial Fibrillation After Percutaneous Occluding of the Left Atrium (MICROPLUG)

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ClinicalTrials.gov Identifier: NCT03361202
Recruitment Status : Recruiting
First Posted : December 4, 2017
Last Update Posted : December 4, 2017
Sponsor:
Collaborator:
Société Française de Cardiologie
Information provided by (Responsible Party):
Institut Mutualiste Montsouris

Brief Summary:

The aim of the study is to compare levels of differnts types of microparticles circulating before and after percutaneous occluding of the left atrium by patients with atrial fibrillation and patients control.

Hypothesis is that prothesis implantation will decrease levels of microparticles circulating in blood circulation because of occluding of the left atrium .


Condition or disease Intervention/treatment
Atrial Fibrillation Other: blood sampling

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evolution of Microparticles Circulating Plasma Concentration in Atrial Fibrillation After Percutaneous Occluding of the Left Atrium With Prosthesis (Amplatzer® Cardiac Plug)
Actual Study Start Date : January 2015
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Atrial fibrillation group
blood sampling
Other: blood sampling
  • atrial fibrillation group:before Percutaneous Occluding of the Left Atrium, at hospital discharge and at J45 follow up
  • control group:before coronary angiography and at hospital discharge.

control group
blood sampling
Other: blood sampling
  • atrial fibrillation group:before Percutaneous Occluding of the Left Atrium, at hospital discharge and at J45 follow up
  • control group:before coronary angiography and at hospital discharge.




Primary Outcome Measures :
  1. levels of microparticles expressing phosphatidylserine in atrial fibrillation group [ Time Frame: 45 days after Percutaneous Occluding of the Left Atrium. ]
    blood samples analized by flow cytometry


Biospecimen Retention:   Samples Without DNA
4 ml of arterial or venous blood


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

two groups of patients:

  • control
  • atrial fibrillation
Criteria

Inclusion Criteria:

atrial fibrillation group:

  • high embolic risk (CHADS-VASC2 score ≥4)
  • formal and final contraindication to anticoagulant therapy
  • no heart thrombus on ETO and TDM before percuraneous occluding

control group:

  • suspicion of stable coronary artery disease, coronary angiography scheduled and double platelet aggregation (clopidogrel and aspirine)

Exclusion Criteria: for both groups

  • congestive heart failure, severe aortic stenosis, EP or TVP early.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03361202


Contacts
Contact: Nicolas AMABILE, doctor +33 1 56 61 nicolas.amabile@imm.fr
Contact: Isabelle SAURET +33 1 56 61 67 05 isabelle.sauret@imm.fr

Locations
France
Institut Mutualiste Montsouris Recruiting
Paris, France, 75014
Sponsors and Collaborators
Institut Mutualiste Montsouris
Société Française de Cardiologie
Investigators
Principal Investigator: Nicolas AMABILE Institut Mutualiste Montsouris

Responsible Party: Institut Mutualiste Montsouris
ClinicalTrials.gov Identifier: NCT03361202     History of Changes
Other Study ID Numbers: CARDIO-01-2015
First Posted: December 4, 2017    Key Record Dates
Last Update Posted: December 4, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes