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)
1 other identifier
observational
50
1 country
1
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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2015
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 12, 2016
CompletedFirst Posted
Study publicly available on registry
December 4, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedDecember 4, 2017
September 1, 2017
3 years
September 12, 2016
December 1, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
levels of microparticles expressing phosphatidylserine in atrial fibrillation group
blood samples analized by flow cytometry
45 days after Percutaneous Occluding of the Left Atrium.
Study Arms (2)
Atrial fibrillation group
blood sampling
control group
blood sampling
Interventions
* 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.
Eligibility Criteria
two groups of patients: * control * atrial fibrillation
You may qualify if:
- 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)
You may not qualify if:
- congestive heart failure, severe aortic stenosis, EP or TVP early.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institut Mutualiste Montsourislead
- Société Française de Cardiologiecollaborator
Study Sites (1)
Institut Mutualiste Montsouris
Paris, 75014, France
Biospecimen
4 ml of arterial or venous blood
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicolas AMABILE
Institut Mutualiste Montsouris
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2016
First Posted
December 4, 2017
Study Start
January 1, 2015
Primary Completion
January 1, 2018
Study Completion
March 1, 2018
Last Updated
December 4, 2017
Record last verified: 2017-09
Data Sharing
- IPD Sharing
- Will not share