- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03361202
Microparticles Circulating Plasma Concentration in Atrial Fibrillation After Percutaneous Occluding of the Left Atrium (MICROPLUG)
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 .
Study Overview
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Isabelle SAURET
- Phone Number: +33 1 56 61 67 05
- Email: isabelle.sauret@imm.fr
Study Contact Backup
- Name: Nicolas AMABILE, doctor
- Phone Number: +33 1 56 61
- Email: nicolas.amabile@imm.fr
Study Locations
-
-
-
Paris, France, 75014
- Recruiting
- Institut Mutualiste Montsouris
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
two groups of patients:
- control
- atrial fibrillation
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Atrial fibrillation group
blood sampling
|
|
control group
blood sampling
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
45 days after Percutaneous Occluding of the Left Atrium.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Nicolas AMABILE, Institut Mutualiste Montsouris
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CARDIO-01-2015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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