Microparticles Circulating Plasma Concentration in Atrial... | NCT03361202

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

NCT03361202

Sponsor

Institut Mutualiste Montsouris

Status

Unknown status

Last Update Posted

Dec 4, 2017Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Atrial Fibrillation

Interventions

blood sampling

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015Actual

Primary Completion Date

Jan 2018Estimated

Completion Date

Mar 2018Estimated

First Submitted Date

Sep 12, 2016

First Submission Date that Met QC Criteria

Dec 1, 2017

First Posted Date

Dec 4, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2017

Last Update Posted Date

Dec 4, 2017Actual

Name	Class
Société Française de Cardiologie	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 .

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Atrial fibrillation group		blood sampling	Other: blood sampling
control group		blood sampling	Other: blood sampling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
blood sampling	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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

two groups of patients:

control
atrial fibrillation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nicolas AMABILE, doctor	Contact	+33 1 56 61		nicolas.amabile@imm.fr
Isabelle SAURET	Contact	+33 1 56 61 67 05		isabelle.sauret@imm.fr

Overall Officials

Name	Affiliation	Role
Nicolas AMABILE	Institut Mutualiste Montsouris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institut Mutualiste Montsouris	Recruiting	Paris		75014	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided