Overview

This trial is active, not recruiting.

Condition atrial fibrillation
Treatment mri 3t
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

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose diagnostic
Arm
(Active Comparator)
mri 3t
(Experimental)
mri 3t
(Experimental)
mri 3t

Primary Outcomes

Measure
quantitative measure of atrial fibrosis
time frame: 4 years

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title Non-invasive Quantification of Atrial Fibrosis by MRI in Atrial Fibrillation
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Assistance Publique Hopitaux De Marseille.