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

NCT ID: NCT03361202

Last Updated: 2017-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2018-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 .

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrial Fibrillation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Atrial fibrillation group

blood sampling

blood sampling

Intervention Type OTHER

* 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

blood sampling

Intervention Type OTHER

* 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

* congestive heart failure, severe aortic stenosis, EP or TVP early.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Société Française de Cardiologie

OTHER

Sponsor Role collaborator

Institut Mutualiste Montsouris

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nicolas AMABILE

Role: PRINCIPAL_INVESTIGATOR

Institut Mutualiste Montsouris

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Institut Mutualiste Montsouris

Paris, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Nicolas AMABILE, doctor

Role: CONTACT

Phone: +33 1 56 61

Email: [email protected]

Isabelle SAURET

Role: CONTACT

Phone: +33 1 56 61 67 05

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CARDIO-01-2015

Identifier Type: -

Identifier Source: org_study_id