Non-invasive Quantification of Atrial Fibrosis by MRI in Atrial Fibrillation
This trial is active, not recruiting.
|Sponsor||Assistance Publique Hopitaux De Marseille|
|Start date||July 2011|
|End date||January 2015|
|Trial size||30 participants|
|Trial identifier||NCT02885883, 2011-04, 2011-A00285-36|
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.
|Intervention model||parallel assignment|
quantitative measure of atrial fibrosis
time frame: 4 years
Male or female participants at least 18 years old.
- paroxysmal or persistent FA (under one year),
- refractory to at least one antiarrhythmic drug therapy
- eligible for an ablation procedure with cryotherapy
- 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 .
- 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)
|Official title||Non-invasive Quantification of Atrial Fibrosis by MRI in Atrial Fibrillation|
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