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

December 1, 2017 updated by: Institut Mutualiste Montsouris

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

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

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
      • Paris, France, 75014
        • Recruiting
        • Institut Mutualiste Montsouris

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

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

Cohorts and Interventions

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.

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

This is where you will find people and organizations involved with this study.

Sponsor

Institut Mutualiste Montsouris

Collaborators

Société Française de Cardiologie

Investigators

  • Principal Investigator: Nicolas AMABILE, Institut Mutualiste Montsouris

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 (Actual)

January 1, 2015

Primary Completion (Anticipated)

January 1, 2018

Study Completion (Anticipated)

March 1, 2018

Study Registration Dates

First Submitted

September 12, 2016

First Submitted That Met QC Criteria

December 1, 2017

First Posted (Actual)

December 4, 2017

Study Record Updates

Last Update Posted (Actual)

December 4, 2017

Last Update Submitted That Met QC Criteria

December 1, 2017

Last Verified

September 1, 2017

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)?

NO

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.

Subscribe