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

Atrial Fibrillation Clinical Trial

— MICROPLUG  

Official title:

Evolution of Microparticles Circulating Plasma Concentration in Atrial Fibrillation After Percutaneous Occluding of the Left Atrium With Prosthesis (Amplatzer® Cardiac Plug)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03361202
• Other study ID #: CARDIO-01-2015
• Status: Recruiting
• Phase: N/A
• First received: September 12, 2016
• Last updated: December 1, 2017
• Start date: January 2015
• Est. completion date: March 2018

Study information

• Verified date: September 2017
• Source: Institut Mutualiste Montsouris
• Contact: Nicolas AMABILE, doctor
• Phone: +33 1 56 61
• Email: nicolas.amabile[@]imm.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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.

Locations

Country	Name	City	State
France	Institut Mutualiste Montsouris	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Institut Mutualiste Montsouris	Société Française de Cardiologie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	levels of microparticles expressing phosphatidylserine in atrial fibrillation group	blood samples analized by flow cytometry	45 days after Percutaneous Occluding of the Left Atrium.