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Non-invasive Quantification of Atrial Fibrosis by MRI in Atrial Fibrillation

NCT ID: NCT02885883

Last Updated: 2018-12-13

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2016-06-30

Brief Summary

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Three groups of patients will be considered: a control group (n = 10); a group of patients with paroxysmal or persistent AF with AF cryoablation procedure - within this group, MRI will replace CT-scan usually performed in routine before the procedure (n = 15); a group of patients with permanent AF (n = 15). MRI study will include pulmonary veins angiography with gadolinium injection (0.20 mmol/kg), 2D-cine imaging and late-enhancement imaging. A 3D gradient-echo sequence(Flash 3-D) will then be applied 20 minutes after the injection, with the following parameters : echo time 0.98 ms, repetition time 2.53 ms, angle 15°, resolution 2.0x1.3x1.0 mm. T1 map and two T2 sequences will be performed so as to determine LA relaxation times. Argus software will be used for post-treatment imaging. Quantitative data will be expressed in mean ± SD. A comparison of T1 and T2 values in LA will be performed between the three groups. Statistics will be performed with SPSS software in bilateral analysis and a value of p \< 0.05 will be considered as significant.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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a control group

Group Type ACTIVE_COMPARATOR

MRI 3T

Intervention Type DEVICE

patients with paroxysmal or persistent AF

Group Type EXPERIMENTAL

MRI 3T

Intervention Type DEVICE

patients with permanent AF

Group Type EXPERIMENTAL

MRI 3T

Intervention Type DEVICE

Interventions

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MRI 3T

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

All persons \> 18 years, which have:

gp paroxysmal or persistant FA

1. paroxysmal or persistent FA (under one year),
2. refractory to at least one antiarrhythmic drug therapy
3. eligible for an ablation procedure with cryotherapy
4. the patient may benefit from surveillance. gp permanent FA permanent AF ( defined as chronic arrhythmia after 2 failed attempts to electrical cardioversion and / or more than one year old) , and hospitalized for cardiac reasons or not in different cardiology Timone .

Exclusion Criteria

* age \< 18 years,
* cons -indications to MRI ( claustrophobia, pacemakers and implantable cardiac defibrillators , metal chips intra ocular , valvular mechanical prosthesis ) , allergy to gadolinium ,
* renal impairment ( creatinine clearance \<60 mL / min)
* pregnant or nursing ( a pregnancy test must be performed for women of childbearing age at the time of inclusion , the result of this test will be communicated to them .
* the MRI examination takes place three months after the inclusion women of childbearing potential should be placed under effective contraception)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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catherine GEINDRE

Role: STUDY_DIRECTOR

Assistance Publique Hopitaux De Marseille

Locations

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AP HM

Marseille, , France

Site Status

Countries

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France

Other Identifiers

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2011-04

Identifier Type: OTHER

Identifier Source: secondary_id

2011-A00285-36

Identifier Type: -

Identifier Source: org_study_id