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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

September 12, 2016
December 4, 2017
December 4, 2017
January 2015
January 2018   (Final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Microparticles Circulating Plasma Concentration in Atrial Fibrillation After Percutaneous Occluding of the Left Atrium
Evolution of Microparticles Circulating Plasma Concentration in Atrial Fibrillation After Percutaneous Occluding of the Left Atrium With Prosthesis (Amplatzer® Cardiac Plug)

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 .

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
4 ml of arterial or venous blood
Non-Probability Sample

two groups of patients:

  • control
  • atrial fibrillation
Atrial Fibrillation
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.
  • Atrial fibrillation group
    blood sampling
    Intervention: Other: blood sampling
  • control group
    blood sampling
    Intervention: Other: blood sampling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
Same as current
March 2018
January 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
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
France
 
 
NCT03361202
CARDIO-01-2015
No
Not Provided
Plan to Share IPD: No
Institut Mutualiste Montsouris
Institut Mutualiste Montsouris
Société Française de Cardiologie
Principal Investigator: Nicolas AMABILE Institut Mutualiste Montsouris
Institut Mutualiste Montsouris
September 2017